What’s New with COVID-19 diagnostic testing and market trends, from IVD market research firm Kalorama Information

Hundreds of Tests on The Market, U.S. Labs Mostly Use Ten

As the COVID-19 crisis surfaced in the United States, molecular diagnostic manufacturers went to work with new RT-PCR testing kits.  There have been hundreds of tests on the market receiving EUAs from the Food and Drug Administration, but a survey from the Association of Molecular Pathology demonstrated that only a few are used by laboratories.  As part of its survey: https://www.amp.org/advocacy/sars-cov-2-survey/ labs were asked their top ten testing methods.   Among them: Abbott m2000, Roche cobas were the top two vendors in most labs’ top tens.

This makes sense, these systems are the ones in most laboratories and the ones that are set up for other RT-PCR uses such as testing for HIV.  Other tests in labs’ Top Tens included: Cepheid Gene Xpert  Roche cobas, Hologic Panther, DiaSorin Simplexa, Quidel Lyra, Thermo Fisher Taq Path, Abbott IDNOW, CDC Test.  There’s still a market for innovators.  Unique near-patient tests, sample collection methods such as saliva or self-test, NGS and mass spectrometry testing, multiple PCR test targets, improved antibody tests, high throughputs, extraction kit workarounds – these  are all examples of areas that innovators can improve.

NOW PUBLISHED: Kalorama Information’s COVID-19 Update – Kalorama’s Analyst Assessment of Impact on Key Markets.

The survey also said that labs have had supply issues throughout the crisis, which they’ve mitigated by using other vendors.

AACC Weighs in on Self-Collection, Antibodies and Other COVID-19 Testing Issues

The American Association for Clinical Chemistry (AACC) has recently taken a position on a number of controversies that have come up as the nation ramps up testing.  Most notably, it spoke in opposition to FDA’s at-home virus kit clearance, following the go-ahead for Everlywell’s kit.  The American Association for Clinical Chemistry (AACC) has notified the U.S. Food and Drug Administration (FDA) that it objected to the agency’s recent emergency use authorization (EUA) of an “unproven” at-home coronavirus collection kit.

The FDA has been approving products related to SARS-CoV-2 rapidly through the EUA pathway. In a letter to FDA Commissioner Stephen Hahn, the AACC said that this haste has resulted in the “introduction of an unproven product into the market.” The letter referenced a product that received clearance on May 16, without noting a product or company name.

The FDA granted emergency authorization to Everlywell’s at-home nasal sample collection kit for COVID-19 testing on May 15, noting at the time that this is the only product of its kind authorized for use with multiple COVID-19 diagnostic tests.

In the letter to the FDA, President Carmen Wiley, PhD, said there is insufficient information about the quality of the product in the EUA.

“A review of the FDA’s EUA to this company does not indicate that adequate clinical studies were performed to validate the kit or that good manufacturing practices were followed to develop it,” she wrote. “Further, the company selling the kit is not a laboratory.”

Increasing access to home-use collection kits can expand testing capacity and meet the need for fast diagnoses, but inaccurate results can do more harm than good, she wrote, urging the FDA to improve transparency in its regulatory decisions.

“We urge the FDA to withdraw its approval of this EUA or release the underlying clinical information that served as the basis for its expedited review,” Wiley wrote. “Authorization for this test kit should not be granted until the FDA has received and assessed the missing information and has released these data to the public.”

AACC guidance also urged caution on rapid POC coronavirus tests. When using rapid point-of-care (POC) tests for the novel coronavirus, healthcare institutions need to monitor the proficiency of operators and make sure the quality of test results isn’t being sacrificed for speed, according to new guidance from the American Association for Clinical Chemistry (AACC) released June 4.  The guidance document on the management of POC testing (POCT) is an update to the AACC’s laboratory medicine practice guidelines/evidence-based practice for POCT, which were published in 2006.

The revised document tackles the following questions:

  • What is the value of an interdisciplinary committee to oversee POCT?
  • Does education improve POCT performance?
  • What is the optimal staffing model for POCT?
  • Do proficiency testing/external quality assessment programs improve POCT performance and patient outcomes?
  • Does data management improve POCT outcomes?
  • How should staff select POCT devices?
  • How does POCT improve process?

In a statement about the release, the AACC highlighted its views on POCT for COVID-19. Institutions should maintain ongoing training for POC operators, track areas that need improvement, and participate in proficiency testing and quality assessment, the AACC advised.

The organization noted problems with rapid tests during the pandemic. In mid-May, the agency alerted the public to problems with Abbott Diagnostics’s ultrarapid ID Now test for COVID-19, which delivers results in 15 minutes. The product will stay on the market, but negative results need to be followed up with a second test and the company needs to conduct postmarket studies to support performance.

“As transformative as these tests are … healthcare institutions need to exercise care in all aspects of their point-of-care testing programs to make sure they aren’t trading [high-quality] test results for speed,” the AACC said in a statement.

The American Association for Clinical Chemistry (AACC) is advising that antibody testing for the novel coronavirus should be limited to diagnostics that have emergency use authorization (EUA) from the US. Food and Drug Administration (FDA) or developed by a CLIA-certified lab.

The AACC also published its recommendations for antibody tests in a new document on May 18. The agency recently revised its policies on antibody testing to require products to get an EUA within 10 days, but there are still issues with test quality, the AACC advised.

“Before implementation of any antibody test, laboratory medicine professionals must also evaluate the test’s accuracy and reliability even if it already underwent FDA review,” the AACC said in a statement about its new recommendations.

The recommendations document includes metrics that may be used for evaluating antibody tests for the novel coronavirus. Antibody tests should not be used as the primary method for diagnosing acute infection or excluding infection in asymptomatic patients. The AACC has also addressed quality of antibody testing in educational videos.

The College of American Pathologists (CAP) also weighed in. CAP elucidated its position on serology testing in a statement from President Dr. Patrick Godbey. Antibody tests have been drawing scrutiny with the entry of a large number of tests that had not been reviewed by the U.S. Food and Drug Administration (FDA). Questions have arisen about quality and validation. The agency recently revised its policies to provide more oversight over antibody tests. CAP’s statement noted that the accuracy of available antibody assays and the clinical significance of positive results are unclear.

FDA Withdraws Chembio COVID-19 Authorization on False Negative Data

FDA has withdrawn Chembio’s EUA for its rapid antibody tests.  Too many false negatives was the culprit, according to the agency.  This was based on data submitted by the company and an independent evaluation by the National Cancer Institute showed the test generated a higher-than-expected rate of false results. The risk to public health from incorrect test results makes EUA revocation appropriate.  The product may not be distributed.

This development highlights the temporary nature of an emergency authorization issued in a crisis, and It does highlight the need for manufacturers to engage in stress testing antibody tests with large numbers of samples prior to manufacture. A test with a high amount of false negatives could obviously be dangerous, and the FDA is showing they are serious about antibody testing and ensuring that only high-performance tests get to keep the EUA.

Chembio has been around a long time and they are POC emerging infectious disease experts with industry standard tests for Zika and Chagas.  The company will likely be able to develop a test on a different platform.

The U.S. Food and Drug Administration (FDA) has published guidance for diagnostics developers that it said will enable broad diagnostic testing of asymptomatic people and sample pooling during the COVID-19 pandemic.

FDA paves way for mass coronavirus screening of asymptomatic people

The template updates provide guidance on validating molecular diagnostics for these purposes and getting them cleared through the agency’s emergency use authorization (EUA) pathway.

“The FDA recognizes that organizations may want to conduct screening of asymptomatic individuals as part of a broader strategy to help ensure the safety of their employees, patients, students and others,” the FDA explained in a June 16 statement.

Guidance on pooling samples during testing is intended as an aid during the pandemic, as it minimizes use of supplies, which have not been adequate. While mixing samples in a batch reduces the number of tests needed and saves on supplies, there is a greater risk for false-negative results. The technique works best when low prevalence of the coronavirus is expected.

“Given that testing asymptomatic individuals means testing a greater volume of patients, and a low prevalence may be more likely in an asymptomatic population, particularly if the population is at low risk for contracting COVID-19, developers may be interested in using pooling techniques in tests used for asymptomatic screening,” the agency said.

Information in the clinical laboratory test section of frequently asked questions has been updated to clarify the FDA’s thinking on testing of asymptomatic people. Most COVID-19 diagnostics that have EUAs from the agency were cleared for individuals with suspected infection. This covers people who are asymptomatic, presymptomatic, and symptomatic, with use guided by a healthcare provider.

Tests need to be specifically authorized by the FDA for broad screening of asymptomatic populations. For this purpose, a highly sensitive test is needed for the most accurate results, and point-of-care tests tend to be less sensitive than laboratory-based tests, according to the agency.

“Although current data suggests that asymptomatic and symptomatic individuals with COVID-19 may have similar levels of viral genetic material in their anterior nares and other upper respiratory sites, there is limited data on the viral loads at different timepoints, in asymptomatic and pre-symptomatic individuals,” the FDA advised.

Guidelines on diagnostic testing from the U.S. Centers for Disease Control and Prevention (CDC), which were last updated on June 13, mainly focus on people who are symptomatic or who have had a known exposure to the coronavirus. However, the CDC also has provided guidance on testing asymptomatic people without known exposure in certain settings where the coronavirus is a particular risk and where regular and broad testing of all may be a good idea, including long-term care facilities, and high-density critical infrastructure workplaces where continuity of operations is a high priority.

Ortho Clinical Diagnostics Nets $678,000 BARDA Grant for VITROS COVID-19 Total Antibody Tests

The Biomedical Advanced Research and Development Authority (BARDA) has awarded Ortho Clinical Diagnostics $678,000 in support of the company’s COVID-19 antibody testing program. Ortho’s total antibody test detects all COVID-19 related antibodies (IgA, IgM and IgG) and Ortho’s COVID-19 IgG antibody test detects the IgG antibody, which appears in a patient’s blood in the later phase of the infection and remains elevated even after recovery. The tests offer greater choice in tracking, surveillance and patient management. As noted on the U.S. Food and Drug Administration’s website, test results also can help aid in determining who may be eligible to donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. The tests run on Ortho’s high-throughput, fully automated analyzers including its flagship VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and VITROS® ECi/ECiQ Immunodiagnostic Systems.

Roche IL-6 Test Receives EUA

Roche announced it received EUA from the FDA for its Elecsys IL-6 test

which measures levels of IL-6 (interleukin-6), a protein that triggers the body’s immune and inflammatory response to fight infections. Because IL-6 is released so early during a severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible. High levels of IL-6 can cause the immune system to begin attacking itself, unleashing a cytokine storm, which has been linked to the deaths of a number of COVID-19 patients.

Roche’s Elecsys interleukin-6 (IL-6) test has received authorization for emergency use from the U.S. Food and Drug Administration (FDA) as a method for identifying COVID-19 patients who are having a severe inflammatory response.  The emergency use authorization was granted on June 2 and Roche said that it is available for use on its cobas e analyzers, which are widely available globally. The test is available in countries that accept the CE Mark in addition to the U.S. The cobas analyzers offer throughput of 300 tests per hour and deliver results in approximately 18 minutes, according to the company.  Elevated IL-6 levels can help alert health providers to patients who are critically ill and at high risk of developing respiratory failure and needing a ventilator, the company noted in a statement. T-cell exhaustion and cytokine storm have been documented in COVID-19 patients, spurring research into Roche’s IL-6 inhibiting antibody tocilizumab (Actemra) as a treatment.

Self Collection OK For Samples: Study

Specimens that were self-collected by COVID-19 outpatients produced diagnostic outcomes that were nearly identical to those from physician-collected samples in a Stanford University study published June 12 in JAMA Network Open. The results suggest that at-home self-collection is suitable for SARS-CoV-2 testing. For the study, researchers compared patient-collected lower nasal swabs with physician-collected nasal and oropharyngeal swabs to see if the collection methods would yield equivalent diagnostic outcomes. They enrolled 30 outpatients who had previously tested positive for SARS-CoV-2 on a reverse transcription polymerase chain reaction (RT-PCR) test. Three specimens (one patient-collected and two physician-collected) were taken in a drive-through testing setting at Stanford Health Care.

The authors noted that if self-collected and physician-collected swabs turn out to be diagnostically equivalent, patients would be able to collect specimens themselves, which could not only increase access to testing but also help reduce healthcare workers’ exposure risk and use of personal protective equipment. However, they cautioned that the results are limited by a small sample size and need to be validated in diverse clinical settings.

For 29 of the 30 patients, the self-collected samples yielded identical results (11 positive, 18 negative) as the physician-collected swabs. In the one mismatched result, the self-collected nasal specimen tested positive, whereas the physician-collected nasal and oropharyngeal swabs both tested negative. This suggests sensitivity of 100% and a specificity of 95% for the self-collected swabs, according to Dr. Yvonne Maldonado and colleagues, who reported their findings in a research letter. The physician-collected nasal and oropharyngeal swabs yielded the same results for all 30 patients.

The authors noted that if self-collected and physician-collected swabs turn out to be diagnostically equivalent, patients would be able to collect specimens themselves, which could not only increase access to testing but also help reduce healthcare workers’ exposure risk and use of personal protective equipment. However, they cautioned that the results are limited by a small sample size and need to be validated in diverse clinical settings.

Commercialization of at-home coronavirus specimen collection has had a bumpy ride. The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for a handful of at-home nasal sample collection kits for COVID-19 testing, including offerings by LabCorp, Quest, and PrivaPath Diagnostics.

However, some tests were marketed to consumers prior to gaining FDA authorization, drawing scrutiny about product quality. In May, the American Association for Clinical Chemistry (AACC) objected to the FDA emergency authorization of one self-collection test, describing the product as “unproven.”

Cue Health Nabs EUA

Cue Health has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its rapid, portable, point-of-care test for the novel coronavirus.  The Cue Health COVID-19 molecular test detects SARS-CoV-2 nucleic acid from a nasal swab sample. It runs a 25-minute analysis directly at the point of care and delivers the results to the Cue mobile app.  The test begins automatically when a nasal swab specimen is inserted into an accompanying Cue COVID-19 Test Cartridge, where heating, mixing, amplification, and detection all occur. The cartridge is connected to the Cue Health Monitoring System, which is in turn linked to an Apple iPhone device.

Cue’s single-use COVID-19 test kit includes the Cue COVID-19 Test Cartridge and sterile Cue Sample Wand. Users must have the Cue Health app installed on an iPhone model 8 or newer for the system to work.

The FDA emergency use authorization allows use of the CUE COVID-19 test at CLIA-certified labs that meet the requirements for high, moderate, or waived complexity tests. It also covers use at point-of-care sites that have a CLIA Certificate of Waiver. Cue hopes to expand the authorization for use in additional locations, such as schools, homes, and workplaces.

The test development received funding from the U.S. Biomedical Advanced Research and Development Authority. Cue is also currently developing additional test cartridges for its point-of-care system, including tests for influenza A and influenza B.


D-dimer Coagulation Test Useful in COVID-19 Severity Assessment

Patients with COVID-19 who have high D-dimer levels are good candidates for CT pulmonary angiography (CTPA) to rule out acute pulmonary embolism (PE), according to a study published June 9 in European Radiology. The findings suggest a way clinicians can better evaluate the embolism risk in patients, since disease severity isn’t necessarily a significant measure, wrote a team led by Dr. Alban Gervaise of Military Hospital Begin in Saint-Mandé, France.

In fact, Gervaise and colleagues found that almost 20% of nonhospitalized patients with COVID-19 referred to CTPA by emergency department staff had acute pulmonary embolism — underscoring the importance of not making assumptions about patients with COVID-19 by the presenting acuity of the disease.

“Severity and radiological features of COVID-19 pneumonia showed no significant difference between patients with or without acute pulmonary embolism,” the team wrote.

Avoid assumptions

Noncontrast chest CT — in conjunction with reverse transcription polymerase chain reaction (RT-PCR) testing — has been shown to be a useful tool for evaluating the pulmonary involvement of COVID-19, the authors wrote. CTPA’s use has been more limited, mostly in patients whose condition has worsened and in whom doctors want to check for acute pulmonary embolism.

Studies have confirmed a link between COVID-19 and acute pulmonary embolism in hospitalized patients with severe to critical illness, but it’s important not to assume that embolism is only present in this population, according to Gervaise and colleagues.

“In our practice, we have found cases of acute pulmonary embolism in nonhospitalized COVID-19 patients referred to CTPA by our emergency department,” they wrote.

The researchers sought to investigate the prevalence of acute pulmonary embolism in patients referred to CTPA by the emergency department. They conducted a retrospective study that included 72 patients who underwent CTPA between March 14 and April 6. Two radiologists evaluated the patients’ scans for acute pulmonary embolism; Gervaise’s team compared the clinical classification (minimal, moderate, severe, critical), lung involvement, and CT total severity score of patients with embolism and those without.

Of the 72 patients who underwent CTPA, 80% also had a positive RT-PCR test for SARS-CoV-2. CTPA identified embolism on 13 scans (18%). Of these, two had main, four had lobar, and seven had segmental acute pulmonary embolism. The most commonly affected lung segments were right lower lobe (61%) and left lower lobe (54%).

The investigators found that mean age and D-dimer values were higher in patients with embolism compared with those without, but they didn’t find a statistically significant difference between the two groups when it came to clinical type, lung lesions, CT severity scores, quality of the CTPA exam, or pleural effusion.


Abbott Releases Interim Study on IDNOW Accuracy vs. Other Tests in Urgent Care

In response to criticism about its IDNOW test, Abbott released an interim analysis of an ongoing multi-site clinical study in urgent care clinics that indicates its ID NOW COVID-19 rapid test is showing strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. The interim results are demonstrating ID NOW COVID-19 test performance is ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when compared to two different lab-based PCR reference methods.

Abbott answers criticism with a study showing IDNOW being used in the function the company says tests are supposed to be used, in active care with a sufficient symptom onset.

Data from this, as well as two other Abbott-sponsored studies – The Everett Clinic in Washington and an ongoing study of hospitalized and nursing home patients – suggest ID NOW performs best in patients tested earlier post symptom onset, when they are most likely to go for care. In these studies, ID NOW was used as intended with variations in patient populations based on the number of days a patient was tested after first experiencing symptoms.

The study found: In 256 subjects enrolled to date, ID NOW has identified 29 of 29 positive samples (100% positive agreement) and 226 of 227 negative samples (99.6% negative agreement) when compared to a commonly-used lab-based molecular PCR assay (the Roche cobas® SARS-CoV-2 assay). In parallel, ID NOW has demonstrated 94.7% positive agreement and 98.6% negative agreement compared to the Centers for Disease Control (CDC) 2019-Novel Coronavirus (COVID-19) Real-Time RT-PCR Diagnostic Panel. In comparison, Roche has demonstrated 95.0% positive agreement and 98.7% negative agreement when compared to the CDC assay. In these subjects, the mean number of days from symptom onset is 4.1 days with 90% of subjects tested within 7 days post symptom onset, when patients typically show up for care.

More info:  https://abbott.mediaroom.com/2020-05-21-Abbott-Releases-Interim-Clinical-Study-Data-on-ID-NOW-COVID-19-Rapid-Test-Showing-Strong-Agreement-to-Lab-Based-Molecular-PCR-Tests

 CDC Warns on Antibody Test Limits

The U.S. Centers for Disease Control and Surveillance (CDC) acknowledged high interest in antibody tests as businesses going back to work, while highlighting their limitations and many unknowns in reopening guidelines.

The agency published a 60-page documentwith guidelines for reopening, in accordance with White House plans, on its website. It includes instructions on testing, tracking, surveillance, and best practices for reopening daycares, schools, and businesses. During a May 20 White House briefing, press secretary Kayleigh McEnany downplayed the release, noting that several policies in the document had been previously published and that overall it represented an aggregation of guidelines on COVID-19.

Serology has been a hot button topic for reopening of economies in the U.S. and around the world. There has been talk of the potential for getting an immunity passport — evidence that one has been exposed to the novel coronavirus and has antibodies against it — as a means to regain entry to communal work environments, but test limitations get in the way. Laboratory medicine organizations have repeatedly flagged the risk for false positives.

In its guidelines for reopening, the CDC wrote that serologic testing “may play a role in a back-to-work strategy provided it can be shown that serologic testing can reliably infer immunity.”

AI-driven app uses blood biomarkers to flag high-risk COVID-19 patients

From Lab Pulse June 3, 2020 — A new mobile app uses artificial intelligence (AI) to assess key biomarkers from blood tests and help clinicians identify patients who are most at-risk for developing more severe cases of COVID-19.

The app’s development was led by researchers at the NYU College of Dentistry, who used data from 160 patients in Wuhan, China to identify four biomarkers in blood tests that were significantly elevated in patients who died from the novel coronavirus:
  • C-reactive protein (CRP)
  • Myoglobin (MYO)
  • Procalcitonin (PCT)
  • Cardiac troponin I (cTnI)

These biomarkers can signal complications, like acute inflammation, lower respiratory tract infection, and poor cardiovascular health. Researchers built a model using the biomarkers and risk factors, like age and sex, and trained a machine learning algorithm to define the patterns of COVID-19 disease and give patients a severity score. After biomarkers and risk factors are entered into the model, it produces a score from 0 (mild or moderate) to 100 (critical).

Read More at: https://www.labpulse.com/index.aspx?sec=sup&sub=lab&pag=dis&ItemID=801305

Quidel Gets Direct w/ New Extractionless Test

Quidel earns an EUA for its Lyra Direct SARS-CoV-2 Assay.  The test  is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (NP) or oropharyngeal (OP) swab specimens from patients with signs and symptoms of COVID-19.  Unlike most other systems, it does not require RNA extraction and instead uses a heating procedure.  This new product means laboratories can work around supply shortages with extraction kits.


Update on Malaysia and COVID-19 Testing

This update is from AcuBiz, a Kuala Lumpur, Malaysia-based consulting services firm: https://acubiz.com.my/battling-covid-19-malaysia-making-steady-progress-with-ivds/

The Malaysian government took quick and effective steps to control large scale gatherings in the country, especially after new infections were traced back to a religious event in February, which was attended by over 15,000 people. With limited knowledge about the new enemy that the country needs to confront, the government acted fast taking effective measures to control the infection from spreading.

IVD companies in ASEAN, which responded to COVID-19 pandemic by launching multiplex RT-PCR tests include Mediven, ADT Biotech, and JN Medsys.

As the country was not equipped to do the required number of tests, social distancing was the immediate choice available for the government. The movement control order (MCO), which became effective on March 18, 2020, played a critical role in containing the spread of the pandemic and saving lives, as the chart below illustrates.

On May 4th, 2020, OECD published a report titled “Testing for Covid-19: A way to lift confinement restrictions”. The report highlighted the role of in vitro diagnostic (IVD) tests as countries worldwide are slowly relaxing the stringent measures taken for implementing social distancing as a measure to control the pandemic. The best exit strategy being recommended is testing, tracking, and tracing (TTT).

The OECD report defines three goals while developing testing strategies as suppressing the resurgence of local outbreaks, identifying people with immunity, and gaining intelligence on the evolution of the epidemic including identifying the threshold for herd immunity. For all the three goals, effective strategies for use of IVDs – molecular as well as serologic tests – are discussed.

Antigen rapid tests have also been approved by the MOH for screening. Malaysia has recently procured 200,000 antigen rapid tests from South Korea-based SD Biosensor, branded as Standard Q Covid-19 Ag. These tests have an accuracy of 84.4% and specificity of 100%. Though not as accurate as PCR tests, these tests offer a cost-effective option for large-scale testing.

Read More: https://acubiz.com.my/battling-covid-19-malaysia-making-steady-progress-with-ivds/

Everlywell Home Test Collection Gets EUA

Everlywell announced that the company has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a COVID-19 at-home collection kit. Everlywell’s EUA is the first to be issued to a digital health company such as Everlywell, which is not a laboratory or diagnostics manufacturer. It is also the only EUA for at-home collection COVID-19 testing that is not tied to one specific lab and allows the company to work with a number of certified labs offering several authorized tests, rather than being limited to a single laboratory or a single test.

The at-home sample collection kit authorized by this EUA enables individuals to obtain a molecular PCR test designed to diagnose the presence or absence of the virus that causes COVID-19 through one of the company’s FDA-authorized laboratory partners. The company will use at least two CLIA-certified high-complexity partner laboratories to process tests at launch, with the intention of adding more laboratory partners as they receive authorization from the FDA for tests using Everlywell’s at-home sample collection kit.    As with the company’s COVID-19 test offering for healthcare providers and organizations, this test kit will also be offered at no profit to Everlywell. The company says its $109 price will cover its costs, such as overnight shipping to the lab, lab processing fees, physician review and diagnosis, and kit components.

CDC flags shortcomings of antibody tests in reopening guidelines

The U.S. Centers for Disease Control and Prevention (CDC) acknowledged high interest in antibody tests as businesses go back to work, while highlighting their limitations and many unknowns in reopening guidelines.

The agency published a 60-page document with guidelines for reopening, in accordance with White House plans, on its website. It includes instructions on testing, tracking, surveillance, and best practices for reopening daycares, schools, and businesses. During a May 20 White House briefing, press secretary Kayleigh McEnany downplayed the release, noting that several policies in the document had been previously published and that overall it represented an aggregation of guidelines on COVID-19.

Serology has been a hot-button topic for the reopening of economies in the U.S. and around the world. There has been talk of the potential for getting an immunity passport — evidence that one has been exposed to the novel coronavirus and has antibodies against it — as a means to regain entry to communal work environments, but test limitations get in the way. Laboratory medicine organizations have repeatedly flagged the risk for false positives.

In its guidelines for reopening, the CDC wrote that serologic testing “may play a role in a back-to-work strategy provided it can be shown that serologic testing can reliably infer immunity.”

But the agency went on to say that despite public optimism about serologic testing to allow a return to work without the need for personal protective equipment (PPE) and other precautions, “there are many unknowns” that limit use for this purpose. For example, it’s unclear how antibodies correlate with immunity and there are concerns about accuracy.

“Typically, a well-performing single-step serologic assay may be expected to have a specificity of 95% (sensitivity is a secondary concern here, although also important), which is likely not enough for this purpose, given the potential consequences of COVID-19,” the CDC wrote. “Combining two different tests will be critical for improving performance and should be part of any strategy to utilize serologic testing for ‘immunity’ determinations.”

Furthermore, performance characteristics are still not known and seroprevalence has been shown to be “highly variable” even within different parts of the same city. If a test with 95% specificity was used in a population with true seroprevalence of 5%, almost half of the positive results would be false, the agency noted.

“At best, the use of serologic testing for a back-to-work strategy would likely benefit fewer than 10% of the population currently,” the document concluded.

The CDC called for a political consensus on top of scientific data to define the role of serological testing as part of business reopening plans.

“Consensus is also needed on a plan for how to provide documentation of that immunity, be it through federal- or state-based immunity registries, digital proof-of-immunity, or physical documentation such as ‘immunity certificates,’ ” the document stated.

In light of the interest in antibody testing, the CDC is working with other government agencies to evaluate assays, while tracking seroprevalence nationally.

Labs Feel the Pinch of Non-COVID-19 Testing Declines

Hospital and Reference Labs are feeling the pinch from the drops in elective surgeries, according to a survey conducted by Kalorama information.  The results were unveiled at a webinar held by Kalorama and The Science and Medicine Group https://vimeo.com/413645455?utm_source=email&utm_medium=vimeo-cliptranscode-201504&utm_campaign=28749

Among the results:

  • Chemistry testing (BMPs, electrolytes, etc) was reported down 19% in volume.  Immunoassays down 21%.
  • Histology testing is down 32%
  • Molecular Testing volumes were up 8%
  • PCT testing was the only other positive test category, up 2%.
  • Blood Gas testing was down only 5%, cardiac troponin down 10%
  • Labs expect to start to use more advanced molecular mass spec and NGS in 2020 and expect to increase chemistry and immunoassay testing as re-openings occur and hospitals reschedule surgeries.
  • Layoffs were a factor at over one half of laboratories surveyed.

Biomerieux Test Designed to Outpace COVID-19 Mutations,

Biomerieux received EUA for its R-GENE COVID-19 test, a 2-test triplex gene assay that tests for multiple parts of the genome.  The test is designed to guard against any mutations in the SARS-CoV-2.   Most tests detect the N “spike” protein and one other area common to coronaviruses to determine a positive.   The R-GENE tests runs for four RNA areas and 2 controls in two separate test runs.

Inside a NY Lab at the Epicenter

An article  in longtime lab management publication Dark Daily explains how Northwell Health Laboratories, located on Long Island, is dealing with the crisis.  The lab used a mobile team of phlebotomists to test residents at home, set up drive-thru tests and used GenMark and Hologic tests early on to boost testing volume and accuracy.  They ramped up their capacity 30x in 14 days, made early calls on the use of nasal swabs to preserve supply, and used data to identify a problem with blood culture ordering.  More here:    https://www.darkintelligencegroup.com/the-dark-report/laboratory-management/at-the-epicenter-northwells-covid-19-lab-data-adds-value-2/   

Swab Supply

Swabs have become an issue, holding up testing because of a lack of supply. But why would there not be supply for so common an instrument? One reason is that there are two suppliers, Puritan Medical Products in Maine and Copan Diagnostics in Italy. Copan is in the center of its country’s own COVID-19 crisis which is causing additional supply delays. Former FDA Commissioner Scott Gottlieb, MD had warned on twitter mid-March that “ The weak link in supply chains are often low margin products, where there’s consolidated suppliers and relative under-investment — precisely because the products are lower margin and therefore don’t attract investment capital. Swabs could be a weak link in broadening testing.” There are some signs of progress from both companies. Puritan said the company was “…ramping up to produce and wrap a million swabs a week that we need to put into the supply chain across the U.S.” (https://www.bloomberg.com/features/2020-coronavirus-puritan-medical-test-swab.) Copan continues to deliver and on March 20th Air Force personnel loaded 13 pallets containing 500,000 COVID-19 testing swabs onto a C-17 Globemaster III cargo aircraft at Aviano Air Base in Italy.

Midturbinate Swab Options?  There has been much coverage of the uncomfortable nasopharyngeal swab and awkward sampling procedure. A common industry refrain is that “you only get one nasopharyngeal swab from a child, you’ll never get one again.” Adults have been experiencing the same discomfort now given the crisis and it’s a popular test location for no one. In addition to discomfort, it is somewhat harder to perform and an error can lead to a mistaken test result, and exposes the test operator for a slightly longer period.  By contrast, midturbinate swab specimens provide amore comfortable sampling experience. The midturbinate reason is halfway between the nasal and the nasopharyngeal area and forms the medial wall of the ethmoid sinus. And in studies of flu tests, there was only a small sacrifice in sensitivity at least in influenza. The CDCs revised guidelines allow them -“Nasopharyngeal swab is preferred, but if this is not possible, an oropharyngeal specimen, nasal mid-turbinate swab or anterior nares specimen will suffice”  A recent study of four hundred eighty-four subjects with nasal, nasopharyngeal and midturbinate swabs obtained for each subject; 14% were children. Showed that the sensitivity for detecting influenza was 98% (95% CI 94.25% to 99.65%) with the midturbinate swab versus 84.4% (95% CI 77.5% to 89.8%) with the nasal swab, difference 13.6% (95% CI 8.2% to 19.3%). Specificity was 98.5% (95% CI 96.6% to 99.5%) with the midturbinate swab versus 99.1% (95% CI 97.4% to 99.8%) with the nasal swab, difference −0.6% (95% CI −1.8% to 0.6%). Swab discomfort levels correlated with the depth of the swab type. Median discomfort scores for the nasal swab, midturbinate swab, and nasopharyngeal swab were 0, 1, and 3, respectively. The tradeoff well worth it. https://www.copanusa.com/swab-flu-season-copan-contour-floqswab-stoppe

Large and Capable Molecular Diagnostics Industry Meets the Challenge

It’s worthwhile to consider that one of the first tasks of DNA-based when they arrived on the scene was the AIDS threat.  The recent production of innovative assays by molecular diagnostics companies demonstrates the industries ability to respond to a new threat, as they had with HIV, Ebola, Zika, West Nile and others.  The molecular diagnostics industry has large and well-financed companies such as Roche, Danaher, BD, Abbott, bioMerieux, Qiagen and Hologic.  We noted last year that the molecular diagnostics market is larger than the economies of many countries. For instance, the market exceeds the individual GDPs of the Kyrgyz Republic at 8 billion or Fiji at $5 billion, or the smallest independent GDP in the world, the tiny 9-island nation of Tuvalu at $48 millions.  More molecular diagnostic instruments and reagents will be sold this year than the GDP of Bermuda, Kosovo, and Sierra Leone, as well as those of 44 other nations,  RT-PCR is the gold standard for virus detection and has taken center stage in the crisis.  30+ tests have received FDA EUA at this time.


Kalorama’s new study on hematology and coagulation finds increased uses of coagulation testing  to determine COVID-19’s unfortunate effects on the blood health of patients.

Coagulation is a complex process in which multiple enzymes and proteins regulate blood flow and clot formation. Coagulation (clot formation), fibrinolysis and platelet aggregation are a part of this process. Fibrinolysis refers to the breakup of blood clots. It is a normal body process that keeps naturally occurring blood clots from growing and causing problems. Anticoagulant drugs help prevent blood platelets from sticking or clumping together, reducing the likelihood that arteries will be blocked by a clot, leading to a stroke or heart attack.

The most widely used drug is Coumadin (Warfarin) that is prescribed for patients with atrial fibrillation, artificial valves and phlebitis. People on warfarin need to have their blood monitored regularly (sometimes weekly and sometimes monthly) to ensure that they are taking the right dosage to avoid clotting if the dosage is too low and also unintentional bleeding when the dosage is too high. This is done with a blood clotting test known as the International Normalized Ratio (INR, formerly known as the
Prothrombin Time test). Proponents of self-testing claim that daily or weekly testing at home helps patients maintain better anticoagulant activity – not too much and not too little.

There are newer oral anticoagulants on the market, such as rivaroxaban (Xarelto), apixaban (Eliquis) and dabigatran (Pradaxa). They are at least as safe and effective as warfarin, and they do not require regular coagulation monitoring with a PT/INR. However, hematologists will use immunoassays to measure the amount of drug concentration in a patient’s blood to assure that the amount of drug is in the therapeutic range. This is akin to therapeutic drug monitoring by immunoassay of antibiotics (gentamicin), antiepileptics (such as carbamazepine, phenytoin and valproic acid), and antipsychotics (such as pimozide and clozapine).

Patients with atrial fibrillation and artificial valves are beginning to switch from warfarin to next-generation drugs. Pharmaceutical companies have heavily invested in direct-to-consumer advertising efforts, ultimately extolling the benefits of these drugs. At this time, this provides another test opportunity in coagulation testing. Several companies have already commercialized tests for the monitoring of the new anticoagulant drugs.

Coagulation testing, including d-dimer, is considered to be a growing indicator in the impact and clinical outcomes of patients with COVID-19. Screening with coagulation panels, including d-dimer, prothrombin time, platelet counts, and fibrinogen, is considered to be essential to identifying patients with severe COVID-19 risk and potential negative outcomes. Several international organizations are leading the charge in identifying and publishing recommendations and guidances for coagulopathy management in COVID-19 patients. Organizations endorsing increasing monitoring for patients with thrombotic diseases and implementing early interventions include:

• American College of Cardiology
• British Society of Hematology
• European Society of Vascular Medicine
• International Society of Thrombosis and Haemostasis
• North American Thrombosis Forum


Kalorama Information’s Hematology Markets

Science and Medicine Group Inc. including Kalorama Information, SDi, BioInformatics, and IMV are marshaling our information and data resources to help those on the frontline in the fight against the COVID-19 virus. Science and Medicine Group Inc. is a market research and media company serving the life science, analytical instrument, diagnostic, medical imaging and dental industries. We also maintain four vibrant communities of more than 300,000 scientists and medical professionals including LabPulse.com, AuntMinnie.com, DrBicuspid.com, and The Science Advisory Board

Today we gave access to our Knowledge Center to employees of the Centers for Disease Control (CDC).   The Knowledge Center is an innovative information sharing platform that enables users to search almost 1,000 detailed reports on a wide variety of diagnostic and medical imaging technologies to understand the science behind the technologies as well as the capabilities and strategies of the market’s supplier base. The CDC will be able to use all the clinical diagnostics from Kalorama and diagnostic imaging from IMV to better coordinate a response among market participants from CT, Ultrasound, Molecular, and Point-of-Care diagnostics. We believe an “all diagnostics on deck” approach to COVID-19 detection would greatly accelerate the detection and also ease the strain on laboratory testing, some of which requires extensive PPE and often has time delays between sample collection and insight.

Kalorama Information, the most trusted name in healthcare and clinical diagnostics market research, has put a large database of diagnostic instruments in the U.S. online free of charge to start-ups, commercial entities developing COVID-19 solutions, and hospitals laboratories so they can locate sites that do testing in the US market. The entire Clinical Masterfile details the manufacturer and model of 39,628 clinical diagnostic instruments at 5,331 U.S. hospitals. Today we are making the COVID-19 instrument part of our Kalorama Clinical Masterfile available for commercial suppliers and local hospitals and labs.  These data will allow national and local hospitals and suppliers to find each other and get the necessary COVID-19 kits, reagents, and controls distributed through national supply chains or local swaps. The list has 1,787 FDA-EUA Approved Instruments or Instruments that can run EUA COVID-19 TaqMan ™ Assays.  We are also releasing 157 Instruments that are COVID-19 capable with Staff Training and Adjustment for Lab Developed Tests. Laboratory professions will be able to use the database to find each other and share reagents and kits needed to maintain their labs’ testing volume.

Bruce Carlson, Publisher of Kalorama Information said, “Market knowledge is essential for developers, potential investors and government agencies.  A crisis brings attention to many markets previously unconsidered, and new employees and agencies need to stay informed with foundational knowledge.  Market research exists for this purpose. Kalorama, IMV and other Science and Medicine Group Publications have available market assessment resources in molecular diagnostics, CT, next-generation sequencing, respiratory point-of-care testing, remote patient monitoring and immunoassays. These tools can provide companies with baseline market assessments to understand these markets which are more important than ever. We are tracking changes in these markets related to COVID-19 though various upcoming publications.”

Dentists and dental hygienists are currently only caring for critical patients but are generally on the frontlines of public health. We believe these practitioners, along with newly developed point-of-care swab tests, will be a key part of community outbreak monitoring once the virus outbreak is under control. To prepare, DrBicuspid.com has made articles and Continuing Education (CE) courses on infection control and PCR available at no charge for dentists and dental hygienists. Our editorial team, lead by Kevin Henry and Dr. David Rice, are prioritizing content to protect these practitioners and prepare them for serving patients once they are able to get back to work serving their patients.

“We know that dentists and dental team members have a lot of questions right now, including when dental practices might re-open on a full-time basis and be able to care for their full patient database,” said Kevin Henry, Editor-in-Chief of DrBicuspid.com. “Our job is to bring experts together from across the industry to answer these questions as well as providing advice on best business practices to help them overcome the financial hardships brought on by COVID-19.”

Science and Medicine Group will continue to look for opportunities to leverage our broad range of capabilities to assist industry and the scientific and medical communities in increasing testing and the development of therapies and vaccines.

“As the world comes together as friends and neighbors to fight the pandemic, we are proud to provide our MasterFile database to researchers and clinicians,” said Jonathan West, Vice President of Business Development. “They are the true “Superheroes” of our time and the entire Science and Medicine Group team is humbled by the opportunity to support them. “

Molecular point of care

We projected in Kalorama’s  mPOC market study that molecular point of care ( mPOC ) would lead the fight in meeting the demand for COVID-19 testing with accurate and fast results.   Lab staff is at a premium, hospitals are taxed, and testing needs to happen where it can be useful to isolate patients.  We suggested that Cepheid was a likely candidate for an early EUA, and that has turned out to be the case.   This was based on the company’s track record with Zika and Ebola, as well as a host of other diseases where it has been a first-mover on rapid molecular tests.

As we suggested might happen and as the company predicted, Cepheid has designed a cartridge that uses the existing platform which will save at least 23,000 locations [5,000 US] from having to buy a new instrument.  They company says it will start shipping on March 27th.

Danaher’s Cepheid on Saturday said it has received emergency authorization from the U.S. Food and Drug Administration to use its rapid molecular test for point-of-care patients that can detect the virus that causes COVID-19 in 45 minutes.

We suggested that Cepheid was a likely candidate for an early EUA, and that has turned out to be the case.   Also, as we suggested, the company has designed a cartridge that uses the existing platform which will save at least 23,000 locations from having to buy a new instrument.

Cepheid said the following in a statement: “During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities.  An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on health-care facilities that need to properly allocate their respiratory isolation resources,” said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.

Other near-patient systems are Credo Biosystems, based in Singapore, which received a CE-Mark for its test, and GenMark’s near-patient e-Plex COVID-19 test, which received an EUA this week.

But Cepheid’s new test is a significant development, for the following reasons:

  • Cepheid has a greater installed base than other systems, and a design that fosters easier use in a clinical setting.
  • The announced speed of 45 minutes is much faster than any approved test we have read of so far, several magnitudes higher than the speed of the approved tests of last week.
  • It  requires no operator training to take the test and determine a result.  This means it can be used in a doctor’s office or retail clinic.
  • 45 minutes is a brief enough time to await results at point-of-care under normal circumstances.
  • Also extraction steps using a kit are not necessary, this is handled in the machine.  There is currently backlogs with such kits at major manufacturers.
  • They are not high-throughput systems, so a test like say a Cobas 6600 in a lab can produce many more test results in a shift, but they are faster so volume is not insignificant.

If one is looking for an example of how fast the IVD industry that Kalorama has observed for two decades can respond to a crisis, this – along with approvals announced by Roche, Abbott, and other firms of mod-complex systems – is evidence.

A rapid scale-up of diagnostic testing for the novel coronavirus was the focus of a declaration of emergency by President Donald Trump in a March 13 press conference. The plan calls for sharply boosting the production of coronavirus test kits while also making tests available at a network of drive-through sites.

In an address at the White House Rose Garden, Trump announced a series of sweeping measures designed to eliminate government regulations that may have been hindering the federal response to the coronavirus outbreak. Most of Trump’s address was devoted to the administration’s plans for making diagnostic testing more available across the country — an issue that has become a flash point for criticism of the administration’s response to the virus.

In his emergency declaration, Trump said that previous government regulation included “very old and obsolete” rules. The new declaration would enable the U.S. Department of Health and Human Services (HHS) to waive rules that may have impeded hospitals and healthcare providers from responding adequately to the coronavirus outbreak. The declaration would also make available $50 billion in federal funding to fight the outbreak.

But Trump reserved the lion’s share of his speech to explain what the administration is doing to make diagnostic test kits more available to test for SARS-CoV-2. Healthcare providers and clinical labs in the field have complained that they have not had enough coronavirus tests available to meet demand, and some have claimed that testing criteria have been too restrictive.

The new plan relies on a combination of making more testing capacity available and at the same time making it easier for Americans to get tested, such as with drive-through testing sites. The administration is also working with Google to set up a website that will enable Americans to determine on their own whether they should seek out testing.

With respect to testing capacity, Trump explained the work the administration has been doing with diagnostics manufacturers such as Roche and Thermo Fisher that builds on a meeting between diagnostics vendors and the government last week.

Roche developed a high-throughput test for the coronavirus, cobas SARS-CoV-2, that received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) within 24 hours of submission of an application. The test’s high-volume capacity should be a step forward in meeting demand for coronavirus testing, Trump said.




Kalorama has released its 12th Edition of The Worldwide Market for In Vitro Diagnostic Tests.  It is a complete market study of the 69+ billion-dollar industry.   Among the report’s findings are the following:

  1. Some Improvement in European IVD Markets: Kalorama found reversed austerity, LDT spending, and test innovation increased Europe market size, somewhat.  As Europe is an important market, this boosted the IVD market as a whole.
  2. New Disease Threats Impacting Blood Bank Market: More nations are testing blood in greater quantities and demand is needed to discover infectious disease threats.
  3. Cancer and Infectious Disease driving Growth – tumor markers, blood-based cancer assays, in situ hybridization are among the cancer tests driving growth.  So is infectious disease testing, both common pathogens such as hepatitis and HIV, but also newer threats such as Ebola, Zika, WNV and others.
  4. Clear Majority (near 60%) of Market Outside US – More growth is coming from more parts of the world.  Look to new emerging markets beyond China, India and Brazil.  Country markets are detailed in this report.
  5. Clinical Diagnostics Usage of Mass Spectrometry Growing – once a research tool, now MS has found its place in diagnostic testing.  Kalorama reports market size and forecasts in this area, for infectious disease and non-micro testing.
  6. Companies “Buy to Grow”  Merger activity is robust in the in vitro diagnostic market as even major players cannot do everything they need to do alone.  60+ acquisitions detailed in this report.

Kalorama’s report provides market sizing and forecasts for every significant in vitro diagnostics test category, including clinical chemistry, immunoassays, hematology, molecular diagnostics, blood banking, inherited disease testing, tumor markers, histology and cytology, coagulation and more.   In addition, trends are covered such as: emerging markets, lab-developed tests, point of care (with market forecasts by POC category), distribution deals and partnerships, NGS in clinical diagnostics, rare disease testing, the current state of PGx and more.    

Reserve Your Copy of The 12th Edition of The World Market for In Vitro Diagnostic Tests

ARLINGTON, VA., The world market for diagnostics is estimated at $69.2 billion in 2019 and is expected to grow a little more than 4% annually to reach $85.2 billion by 2024. This is according to an upcoming report by market researcher Kalorama Information, part of Science and Medicine Group. This estimate includes all laboratory and hospital-based in vitro diagnostic tests instruments and reagents, and OTC product sales.

Kalorama Information released the 12th edition of its 2,000-page  Worldwide Market for In Vitro Diagnostic Tests and has made a special offer available exclusively on its site.

Kalorama cited companion testing and demand for personalized medicine, demand for improved infectious disease testing, and sales to China and other nations as reasons for increasing sales. There are limits to growth however; such as the actions of developed-nation governments to reduce reimbursements and the severe drop in the glucose market recently due to cheaper meter competition.  Consolidation of labs continues to be a market limiter as well.  The market is also boosted by the aging world population and the stream of new test innovations – this is a field where double-digit percentages of sales invested back in R&D is not uncommon – and the market is offset by reimbursement cuts worldwide and slower buying in mature sectors.  Mass spectrometry has arrived, the report said. Once an instrument in research it is now an essential part of microorganism identification, drug testing and other applications.  For the second time, we include reporting on mass spectrometry clinical testing in the report. and it makes a contribution to the market and to growth.

The firm includes hundreds of firms in in its report but said that Roche, Abbott Diagnostics, Siemens Healthcare, Danaher, Thermo Fisher Scientiic, bioMerieux and Ortho Clinical Diagnostics are among top tier competitors.

Some other findings of the report:

  •  Roche leads, Abbott is 2nd.  But no company, not even these large IVD companies, owns all the technology to compete in an increasingly complex world. Chapter 2 of the report lists over 60 recent mergers and acquisitions related to IVD. Significant recent deals. Last year Abbott brought POC leader Alere into its operations, completing an acquisition finalized in 2017.  Recently, Meridian Biosciences purchased GenePOC.
  • Major chemistry vendors are developing improved models selling their existing customers on staying with them – to preserve and expand revenue, as well as create barrier entry against other vendors in a shrinking lab environment. Footprint improvements, IT enhancements, EMR, automation and expanded menus are part of this change.
  • Mass spectrometry has gone from a research tool to a significant category in the market, especially in developed markets, for the identification of bacteria, fungi and mycobacteria. The MALDI-TOF market has exploded in recent years in microbiology labs, thanks largely to the IVD regulatory approval of the VITEK MS and MALDI Biotyper.  There are limitations, throughput and operator experience among them.|
  • A clear majority of the market is outside the United States. All of the major IVD companies reported double-digit increases in their sales in China with growth in the other top emerging markets: Brazil, Turkey, Korea, India, Saudi Arabia and Mexico. Other emerging markets of interest for IVD vendors were Colombia, UAE, South Africa and the Eastern Europe region. These countries continue to invest in healthcare infrastructure and insurance coverage for a growing more affluent middle class.
  • The market continues to grow, but what the dollars represent is changing. Twenty years ago, clinical chemistry and immunoassays were most of testing. Still today, the traditional core lab test segments – chemistry/immunoassay, hematology and coagulation – make up 34% of the dollar value of the IVD market in 2019, while they are over sixty percent of tests run. As molecular, infectious disease, and cancer tests increase in importance, the market share of these core tests will decrease to 29% in 2024.
  • Sepsis is a growing problem and early detection is crucial for patients. Approximately 1.7 million individuals in the US develop sepsis each year and there is currently no gold standard for diagnosis in the clinical setting. Procalcitonin (PCT) and lactate are two established biomarkers for sepsis, but there are limitations. Several European studies have reported reduction in antibiotic usage with PCT-guided decision making, but a large multi-center US discussion did not show results. A novel marker, Human Neutrophil Lipocalin (HNL), a glycoprotein released from activated neutrophils during bacterial infections, has attracted some attention.

Kalorama Information attended the American Association of Clinical Chemistry in Anaheim this year.    We analyzed products and trends, interviewed vendors and experts, and gathered information for our 12 Edition Worldwide Market for In Vitro Diagnostics Tests report, due out this month.

Time is of the essence, it is said, and that was the case in Anaheim at the latest AACC.  As in other years, Kalorama found that vendors emphasized time-savings in their pitches.  That meant saving lab staff time, increasing walkaway time, reducing sample-to-result time, increasing test-to-treatment time.  Faster tests were on display, and “better” tests too.   Tests that are more sensitive, more precise, test instruments with operator assists such as decision aids, management IT and automated features.  These are features that vendors hope will help retain customers in a shrinking lab environment. In the scientific sessions and on the Clinical Expo floor, vendors and speakers focused on improvements in testing and patient care.  There was a clear demand for biomarkers that can really inform therapy, and a need for a better solution on sepsis.

Developments of note in the first day of the Clinical Expo include.

“Disruptive” Sepsis System wins Prize.   Sepsis is oft misdiagnosed; hence the plethora of discussion and exhibits on the disease at AACC over the years.   Inflammatix’s in-dev 30 minute sepsis test attracted attention and an award.  Their product  HostDx Sepsis, a highly specific diagnostic test that can identify the type and severity of a patient’s infection in less than 20 minutes.  The company claims the product enables early detection of both bloodstream and non-bloodstream infections.   The product uses mRNA and gene signature technology, and according to the makers, detecting changes in gene expression across a range of messenger genes  creates greater granularity than markers such as PCT.   The intention is to direct better treatment.   The product is in the early stages and clinical trials are not yet performed.

Improvements to dPCR, colon cancer testing and mass spectrometry were also among the innovative tests that received Disruptive Technology awards.   CombiNATI is  an in-dev 16 sample-per-plate dPCR platform that aims to compete with market leaders Bio-Rad and Thermo in the burgeoning dPCR field.  The company was a semi-finalist in the awards.  La Jolla-based Singelera Genomics was a finalist for their ColonES colorectal cancer screening assay. The circulating tumor methylated DNA (ctmDNA) test.   The company claims ColonES is an accurate test that is non-invasive and uses blood samples rather than stool  the sample used for Cologuard and other fecal occult blood-based tests.   The award might be indicative of a need for a simpler sampling method.

AACC President Touts POC Platform, Takes on PAMA: In an interview with LabPulse.com  AACC 2019 President Carmen Wiley, PhD talked about top presentations at the conference, as well as some of the major issues facing clinical chemistry right now.   She previewed important plenary sessions; presented the LabTestsOnline.com website, which is meant for the layperson and efforts of AACC to go to Capitol Hill and meet with representatives.

“The A in PAMA is supposed to represent access, and it actually does the opposite. The most vulnerable patients are going to be affected, because they won’t be able to obtain the tests they need. ”
-AACC President, Carmen Wiley, PhD, LabPulse Video Interview

She also mentioned the grass-roots efforts to get members to write to their representatives about laboratory medicine issues, and touted the POC certification program that has 32 diplomates already: “Testing is leaving the core laboratory and going out into other areas, and we want them to have a strong foundation,” she said.   Wiley also promoted the work the organization is doing with PAMA. “The A in PAMA is supposed to represent access, and it actually does the opposite. The most vulnerable patients are going to be affected, because they won’t be able to obtain the tests they need. ”

Roche Bets on Precision, Deep Analytics, Presents Tumor Board Review Tool:  Roche Diagnostics is the #1 IVD company in the world according to Kalorama Information’s The Worldwide Market for In Vitro Diagnostics.  They compete in all major sectors, but with traditional in vitro segments such as chemistry and glucose at low-growth levels, the company made a noticeable shift to possibly game changers like big data and deep analytics.    This was evident at its press conference on Tuesday of the meeting, which Kalorama attended.   VP Rod Cotton and VP for Information Diagnostics Ketan Paranjape presented their solutions to enhance teams of doctors participating in tumor board review.  “Scientific knowledge doubles every 80 to 90 days,” said Paranjape.  “We have to find meaningful ways to add value.”

Roche’s foray in this area is the NAVIFY Tumor Board 2.0, a cloud-based product resulting from a partnership with GE Healthcare, integrates and presents patient data along with relevant scientific data. A single, standardized dashboard with GE enables viewing of DICOM and manually uploaded digital image files.   And the seamlessly incorporated application ecosystem enhances tumor board preparation and presentation to support the clinical decision making of oncology teams.

In other news, Roche announced that longtime CEO of Roche Diagnostics’ North American operations Jack J. Phillips was leaving the company.  Media reports indicate he left to join Accelerate Diagnostics.

Roche announced instrument system additions as well, including their cobas  Pro Integrated Solution— An integrated mid-to-high volume solution for clinical chemistry and immunochemistry testing needs that is designed to achieve reduced maintenance and increased throughput through a scalable and modular system.  The system is not available for use in the U.S. pending 510(k) clearance.  They also featured cobas Prime — A pre-analytical system designed for standard processing and cross-contamination control of molecular samples. This system is also not available for use in the U.S.

Pro-Keto Diet Study Unveiled at AACC – In recent years, numerous contradictory dietary guidelines have come out, leaving the public confused about what is truly healthy to eat. The American Heart Association recommends an ideal upper salt intake limit of 1.5 g/day for adults in order to prevent high blood pressure and cardiovascular disease. However, in 2013, the Institute of Medicine came out against cutting sodium levels below 2.3 g/day. So which organization is correct? The answer turns out to depend on an individual’s genetically determined salt sensitivity.

By the end of the study, mean blood glucose and HbA1c levels had dropped for 110 of the participants, going down to 137 mg/dL and 6.43%, respectively.

This new test and a second study showing that the ketogenic diet improves diabetes symptoms were presented   Kanchana Lakshmi Prasanna Angati, MD and other researchers recruited 115 Indian type 2 diabetes patients to follow the keto diet for 3 months. At the start of the study, participants’ mean blood glucose and hemoglobin A1c (HbA1c) levels—both of which reflect blood sugar levels—were 169 mg/dL and 7.8%, respectively. By the end of the study, mean blood glucose and HbA1c levels had dropped for 110 of the participants, going down to 137 mg/dL and 6.43%, respectively.

Ortho Clinical Diagnostics Wins Service Awards:  for the fourth consecutive year, its Ortho Care™ service and support program was ranked No. 1 in the diagnostics industry. The rankings were published in three IMV 2019 ServiceTrak™ reports, which are based on opinions of laboratory professionals working in U.S. hospitals representing more than 3,000 systems.

Kalorama spoke with Michael S. Iskra, President of North America Commercial Operations for Ortho, as well as Clinical Lab Portfolio head Piper Antimarino.  The company unveiled the VITROS XT 3400, which is currently under development and is intended for smaller laboratories that do not require the full menu and full throughput of the VITROS XT 7600. The company says the VITROS XT 3400 will also employ Ortho’s dry-slide technology that eliminates washing and other steps, which can normally introduce errors in testing.

Ortho’s message: Automation of basic tests contributes to precision.  Freeing up bread-and-butter tasks performed by laboratory staff can ensure that laboratorians have time for novel testing that needs to be done.

While awaiting FDA clearance, the product boasts a 3x performance boost over the company’s existing VITROS model, while saving space.  “In order for labs to perform more novel tests, we want to free up labs from the the bread and butter tasks,” Iskra told Kalorama.

Ortho Clinical Diagnostics Unveiled its Ortho’s VITROS XT MicroSlide which uses an advanced digital imaging optics technology that allows labs to simultaneously perform two tests that are commonly ordered together from a single small blood sample. The company claims this new tech gleans significantly more information from each test than before, improving performance, saving time and space in the lab, and increasing productivity, with less patient sample required for testing. Ortho’s VITROS XT MicroSlides, which include VITROS XT UREA-CREA, TRIG-CHOL and GLU-Ca Slides, have received CE Mark and are available on the VITROS XT 7600 Integrated System.

Solving Disease Mysteries with Precision Med– Millions of individuals in the U.S live with a rare disease. Using genome sequencing, some of them have received answers. Euan Ashley, MB ChB, DPhil, of the Stanford Center for Inherited Cardiovascular Diseases, highlighted new genomic sequencing technologies that could drive precision medicine forward, while also exploring precision medicine’s likely near-term uses—such as in solving the mystery of unidentifiable diseases. Dr. Ashley presented compelling cases from the Undiagnosed Disease Network that demonstrated the potential of precision medicine to better characterize rare diseases. The network diagnosed 200 patients that previously had an unknown disease. Of those, 40 patients were able to find a targeted therapy to treat the disease. These are small numbers, relative to the total number of patients, but indicative of what larger funded efforts could do.

70-Second BMP: Instrumentation Laboratory (IL) today announced the unveiling of their latest innovation, the GEM Premier ChemSTAT.  The system is a whole-blood analyzer designed for rapid basic metabolic panel (BMP) testing at the point of care, primarily in hospital Emergency Departments (EDs) and Clinical Laboratories.  The system provides laboratory-quality results on-demand, in less than 70 seconds, from venous or arterial whole blood samples, with no preparation required.

Laboratory-quality BMP results on-demand, in less than 70 seconds, one of several products aiming to slice test time.


Three-Minute HbA1c Test On Display:  HbA1c is an established marker, but its important to note the developments in the interfaces and formats for A1c tests.  Abbott displayed its recently FDA-cleared Afinion™ HbA1c Dx assay is now available for use on the Afinion 2 and AS100 Analyzers.  Abbott says the Afinion HbA1c Dx assay is the first and only rapid point-of-care test cleared by the U.S. Food and Drug Administration (FDA) to aid healthcare professionals in the diagnosis of diabetes and the assessment of patients’ risk of developing the condition.  The test delivers accurate and precise glycated hemoglobin (HbA1c) results in only three minutes, enabling clinicians to diagnose patients and help them formulate individualized care plans during a single doctor’s office visit.

90-Second Lipid-Glucose Combo: PTS Diagnostics presented a CardioChek Plus analyzer and PTS Panels Lipid Panel + eGLU Smart Bundle. The company says these products help clinicians save time by simultaneously testing lipid panel and glucose.

Game Changer on Lyme Disease? Lyme Disease cases are up, public awareness has grown, and tests are simply inadequate to detect the disease in most patients — too many false negatives to call existing products successful. This has been widely acknowledged. Genetic tests are in development. But another way is to take the existing technologies and double them up.   ZEUS Scientific promoted ZUES MITT – a double immunoassay system which the company claims can detect 30% more acute cases than the immuno/WesternBlot combo.

AACC Aims at Africa:  AACC announced an expansion of The Global Lab Quality Initiative (GLQI) to Africa next year.  The program circulates testing best practices, providing method verification workshops and other training and education.  For 8 years, the GLQI has worked with partner associations in Latin America and the Pacific region.   A quality control workshop is slated for Ethiopia in 2020, and a newborn screening workshop is planned in Morocco in the coming year.

More than half of global population growth between now and 2050 is expected to occur in Africa, according to the U.N.

As lab quality, tools and possibly information systems better take root in these countries, Kalorama sees an important marketplace to watch long-term.  The African Federation of Clinical Chemistry (www.afccafrica.org) counts labs in fifteen countries among her members.   Kenya, Nigeria and South Africa are among countries with established clinical chemistry societies of their own.

Biomarker Discovery is Not Enough: Researchers may be developing more biomarkers than needed.   And there are thousands of tests of dubious value.  This was the conclusion of a plenary talk by David Walt, PhD – “Biomarker Discovery from Technology Development to Clinical Application” emphasized that the genertic technology he helped to foster (Walt is the developer of microwell technology) is creating an overwhelming amount of biomarkers, but not yet optimizing patient care.   Dr. Walt told two “stories of technology development” that illustrate how long it can take research technology to reach the diagnostics market, asking “how can we bring transformative technology to the clinic?” By the time such companies begin to address the diagnostics market, their revenue stream is already strongly tied to research markets. He said few companies participate in both the research and diagnostics markets.He went on to propose an alternative that would see the process reversed.

By the time research companies begin to address the diagnostics market, their revenue stream is already strongly tied to research markets.

He emphasized that developers need to start with an unmet clinical need and approach with an eye to clinical utility.    Innovation does not always improve the clinical work up.  More detail and analysis of Dr. Walt’s talk is provided in Instrument Business Outlook. 

Testing for CBN and THC Differs, Study Shows: A study of immunoassays used for detecting tetrahydrocannabinol (THC) — the psychoactive part of marijuana — found that other types of cannabinoids have the potential to give a positive result, researchers reported on August 5.  Cannabinol (CBN), which is marketed as an over-the-counter sleep aid, gave a positive result on one of two THC immunoassays tested in a study of urine samples taken at Arup Laboratories, a nationwide clinical and anatomical pathology reference laboratory and a nonprofit arm of the University of Utah.    The researchers also tested three other types of cannabinoids in urine samples — cannabidiol (CBD), cannabichromene (CBC), and cannabigerol (CBG) — but did not identify the same cross-reactivity issues reported for CBN.  The study shows the unknowns for consumers and laboratories alike regarding effects of cannabinoids and risks for false positives in drug tests. The legalization of marijuana in some U.S. states and the first approval by the Food and Drug Administration of a prescription-grade formulation of CBD (GW Pharmaceuticals) for a rare form of epilepsy has given a stamp of legitimacy to cannabis-derived products. CBD may be stealing the headlines nowadays, but according to the University of Utah researchers, CBN is also commonly used and may affect lab results.

Quest for Sepsis Silver Bullet Continues: procalcitonin (PCT) and lactate are two established biomarkers for sepsis, but there are limitations.  A Session entitled  “The Journal of Applied Medicine Hot Topics of 2019” discussed these limitations, and the progress on new markers.  Several European studies have reported reduction in antibiotic usage with PCT-guided decision making, but a large multi-center U.S. discussion did not show results.   A novel marker, Human Neturophil Lipocalin (HNL) was discussed.  HNL is a glycoprotein released from activated neutrophils during bacterial infections. It can distinguish between bactertial and viral infections with greater than 90% accuracy, according to Robert Christenson, PhD, Editor in Chief of The Journal of Applied Laboratory Medicine.  bioMerieux, Diazyme, iCubate, Nova Biomedical, Response Biomedical, VITRO, Joinstar Biomedical Technology Co. are among the companies that presented sepsis products at the meeting.

The understanding of sepsis is changing.  A recent JAMA study, based on EHRs, which found that sepsis has at least four types labelled alpha (α), beta (β), gamma (γ), and delta (δ) — with different demographics, laboratory values, and patterns of organ dysfunction.(https://www.medpagetoday.com/meetingcoverage/ats/79

Opioids: AACC released a position statement at AACC calling for increased collaboration between clinical laboratories, the healthcare community, and federal agencies to end the opioid epidemic. The statement emphasizes that labs are critical to preventing opioid abuse and urges the medical community and government to leverage the expertise of clinical laboratory professionals to curb soaring drug overdoses in the U.S.

From 2016 to 2017, fatal overdoses caused by synthetic opioids jumped by 46%, a surge that contributed heavily to the more than 70,000 drug overdose-related deaths in 2017. Synthetic opioids are so deadly because of their extreme potency, but also because common tests often can’t detect them. This makes it difficult to determine whether synthetic opioids are the cause of a drug overdose and to detect when a patient is abusing synthetic opioids. The AACC is betting that laboratories with the appropriate experts and the right instrumentation and tests can identify many synthetic opioids that would otherwise be missed. Without this information, patients might not get crucial addiction or overdose treatment. Clinicians especially need to know if an overdose is due to a long-lasting synthetic opioid, because in these cases patients may need additional doses of the opioid antidote naloxone to prevent a relapse of overdose symptoms.

Quidel Promotes New Drug Test: launched its Triage TOX Drug Screen, a fluorescence immunoassay to be used with the Quidel Triage MeterPro System for detection of   acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.  The MeterPro is a comprehensive test menu a diverse immunoassay menu in a variety of tests including BNP, CK-MB, d-dimer, myoglobin, troponin I.

Boosted Mass Spec with New Emitter: For Mass spectrometry (MS) to work in clinical diagnostics two enabling developments will be required. Throughput for the clinical environment, and the adaptation to immunoassays.  Newomics, a semi-finalist at the AACC Most Disruptive Technology Awards claims to have done both, and was recognized by the association for their work.  They have developed a novel, sensitive, robust, and fast MS assay to quantify intact proteins directly from human plasma without immunoprecipitation or digestion. Newomics has developed a top-down parallel reaction monitoring-MS (PRM-MS) assay that the company claims has a sensitivity (0.1−1.0 fmole) and speed (1−5 min) on par with ELISA.

For mass spectrometry to work in clinical diagnostics, throughput for the clinical environment, and the adaptation to immunoassays will be required.

Newomics produces emitters (M3 emitters) that they say enable optimization of sensitivity, throughput and robustness for LC-MS by splitting the LC eluent evenly into multiple flows at the emitter, thereby dramatically enhancing the ionization efficiency. The first commercially-available M3 emitter has been optimized for microflow LC – nanospray MS and can easily be configured for the Thermo Scientific microflow LC-MS systems and the Thermo Scientific Nanospray Flex ion source. The company has a co-marketing agreement with Thermo Fisher Scientific.

Molecular Point of Care:  PCR systems at the near-patient level are one of the more innovative technologies in IVD. Kalorama Information’s report estimated a more than $400 million-dollar market for PCR and other NAAT-based tests at the point of care. Abbott, Cepheid, BioFire (bioMerieux) and Roche lead in this segment, but Quidel, Meridian, Mesa Biotech, and Biocartis are among those with offerings as well. Credo Biomedical, a Singapore-based developer of systems for veterinary diagnostics, launched their new molecular diagnostic platform, VitaPCR, and its Influenza A/B assay. Credo is boasting cost-advantages, the system delivers lab- accurate results in less than 20 minutes with only 2 minutes hand-on time at the same price level as traditional lateral flow tests. The product is especially aimed at NGO markets, and is under development pending approval from major authorities.

Diabetes: Given the unfortunate incident rates and the severity of the disease, this is an important area for test innovation and this was evident at AACC 2019.   Revised American Diabetes Association standards since the last AACC annual meeting – https://www.aacc.org/publications/cln/cln-stat/2019/january/17/new-diabetes-standards-of-care-what-labs-need-to-know. may increase vendor focus on new hbA1C testing systems. The annual National Glycohemoglobin Standardization Program and IFCC Manufacturer Forum met at the Hilton Anaheim during the meeting.   The group sets test certification standards.  In terms of vendors, EKF Diagnostics displayed their now FDA-cleared glycated albumin test, used for intermediate term monitoring of glycemic control in diabetes patients. Glycated albumin is measured when diabetes therapy is initiated to determine medication regimens and doses and to assess overall therapy efficacy. Nova Biomedical offered several seminars at the meeting related to diabetes, including “Regulatory Requirements and Legal Consequences of Off-label Glucose Testing Rapid Diagnostics for Electrolyte Imbalances in Sepsis”,” Rapid Diagnostics for Electrolyte Imbalances in Sepsis”, and “Regulatory Requirements and Legal Consequences of Off-label Glucose Testing” Roche Diagnostics promoted its Accu-Chek® Inform II system The company says the wireless meter and test strip technology, along with its connectivity solution work together to provide reliable results in 5 seconds.

NAFLD and NASH: Nonalcoholic fatty liver disease (NAFLD), in which fat deposits in the liver, affects over 1 billion people globally and is projected to become the leading cause of liver-related mortality within 20 years. Siemens Healthineers sponsored a “Managing Patient Pathways and Improving Outcomes in NAFLD and NASH” Tuesday, August 6 in the Exhibit Hall. Of note: According to the National Institute of Diabetes and Digestive and Kidney Diseases, the prevalence of this disease is more significant in the U.S. NAFLD affects between 30% and 40% of American adults. NAFLD is one of the most common causes of liver disease in the United States. Most people with NAFLD have simple fatty liver. Only a small number of people with NAFLD have NASH. Experts estimate that about 20 percent of people with NAFLD have NASH. Caspase-generated fragments such as cytokeratin-18 (CK-18) in patients with various hepatic impairments are investigated as markers for diagnosis and assessment of disease severity. cytokeratin-18 (CK-18) CK-18 is the most extensively evaluated analyte for NASH diagnosis. Ray Biotech, Arup, Millipore Sigma and Thermo Fisher were among vendors with CK-18 antibody products.

Alzheimer’s Disease Progress: Blood metabolites could one day help predict which patients with Alzheimer’s disease will experience relief from cognitive symptoms through exercise therapy, based on preliminary data presented on August 5 at the American Association for Clinical Chemistry (AACC) conference in Anaheim, CA.  A team of researchers led by Danni Li, PhD, and Fang Yu, PhD, both from the department of laboratory medicine and pathology at the University of Minnesota, identified the metabolites in a study of 26 patients.

Prior research has suggested that exercise enhances cognition in Alzheimer’s disease and reduces the accumulation of amyloid plaques in the brain. In light of the many failures of drug treatment, exercise has become an increasingly important area of research for this common and disabling condition. In the U.S., one of every three seniors has Alzheimer’s or another form of dementia at the time of death.

While the research is encouraging, authors emphasized that it is still preliminary; the results must be validated and replicated. A new follow-up clinical trial of 120 patients that will combine exercise and cognitive training as an intervention for cognitive impairment is in the planning stages. The follow-up trial will also look for metabolites associated with improvements in patients’ cognitive abilities.


Biotin: A session at AACC 2019 “Beautiful Skin and Erroneous Lab Results” dealt with biotin or B7 and its interference with testing some immunoassay methods.  Biotin is an issue as it is in some foods but also in commonly consumed supplement products for hair, skin and nails.  The supplements can be higher than US RDA and throw off testing results.  The session suggested ways to deal with interference, such as testing for biotin and adjusting results.  That doesn’t mean all labs will do that, thus this trend is one where some vendors can prosper:  Tosoh Bioscience presented its biotin free assay menu ST AIA-PACK.  The increase in biotin supplementation use combined with the limitations in many immunoassays, the company says, has led to false lab results, misdiagnosis and mismanagement of patients.  The FDA to issue a warning against biotin interfering with some lab tests.  Abbott diagnostic tests are also biotin-interference-free, according to the company.

Testing and Transgender Patients:  Laboratorians should be aware of transgender patients and how hormone therapy can change lab values, due to the lack of test reference values for this subset of the population, according to a pathologist who presented long-term data on August 5 at the American Association for Clinical Chemistry (AACC) conference in Anaheim, CA.   The retrospective study examined lab test results from charts of 147 healthy transgender people over five years, including a comprehensive metabolic panel, complete blood count, and lipids.  Hormone therapy can affect lab values — for example, low-density lipoprotein cholesterol, red blood cell count, and kidney function — and it’s an issue for those who transitioned to female and are on estrogen therapy, as well as for male patients taking testosterone.

Laboratorians should be aware of transgender patients and how hormone therapy can change lab values, due to the lack of test reference values for this subset of the population.

New Sickle Cell Rapid – Fast diagnosis of sickle cell disease is necessary RBCs containing evidence of the disease live only about 16 days compared to 120 days for normal red blood cells. To initiate life-saving therapies, early diagnosis of SCD is key.   Absent treatment, severe complications can occur.  BioMedomics launched its Sickle SCAN —  a multiplexed, qualitative, point-of-care immunoassay used for the rapid diagnosis of sickle cell disorders. The test is made up of three indicators which detect the presence of hemoglobins A, S, and C, allowing the user to rapidly distinguish between normal, carrier, and sickle cell disease samples.


CRP Rapid: Orion Diagnostica presented its FDA-cleared QuikRead Go CRP, an immunoturbidimetric assay for the in vitro quantitative determination of C-reactive protein (CRP) in K2-EDTA and lithium heparin whole blood, K2-EDTA and lithium heparin plasma, and in serum sample. The company says that QuikRead Go makes it easy to add patient and/or operator identification information together with the result which is automatically stored in the instrument’s internal memory.

Automation Developments for Mid-Size Labs: Analyzers with automated features were a common offering at AACC – ERBA Mannheim unveiled its NEXUS next generation automation at AACC 2019. Erba’s Hematology system uses unique combination of ultra-high definition imaging, artificial intelligence (AI) and traditional methods to analyse thousands of blood cells per minute to improve turn-around time Immunoassay system uses high sensitivity CLIA technology with proprietary magnetic bead design with menu of over 100 parameters Chemistry system uses advanced thick-film ISE analysis technology and innovative reagent management to deliver improved workflow and enhanced analytical result quality.  Festo introduced a new low-weight, high-accuracy 96-channel bulk dispense head, which offers an economically effective way to distribute bulk reagents at high throughput. The system can be made compatible with various liquid handling robots or supplied as a standalone automated sample preparation system. The company said Most bulk-dispense heads are heavier and require more costly motion units to handle the greater torque requirements.

Beckman Provides Automation Across Lab Sizes, Wins Performance Award:  Beckman Coulter introduced its “Automation for All” strategy that includes a scalable workflow solution that complies with the cost and space requirement s of small to large clinical laboratories.  The new automation products include:  Command for larger labs, Advance for medium-sized labs, Connect for small labs.

Beckman Coulter announced that its MicroScan WalkAway family of instruments has once again received IMV ServiceTrak’s “Best System Performance” award in the AST/ID category. ServiceTrak™ Clinical Laboratory Awards are based on interviews conducted with respondents in 2,075 clinical testing locations. The award in each category is given to manufacturers that receive the highest percentage of highly satisfied customer responses. The Best System Performance award was presented to Beckman Coulter today at the 71st AACC Annual Scientific Meeting & Clinical Lab Expo in Anaheim, Calif.

Benchtop Automated AST System:  Thermo launched a benchtop automated reading and incubation system for antimicrobial susceptibility testing (AST) and new sustainable culture media plate technology at this week’s American Association for Clinical Chemistry (AACC) annual meeting in Anaheim, CA.   Sensititre Aris HiQ AST from Thermo Fisher Scientific is a new benchtop automated reading and incubation system for antimicrobial susceptibility testing.

Thermo Fisher Scientific said that it has collaborated with pharmaceutical companies to include a large selection of antimicrobials, enabling access to new therapies for multidrug-resistant infections.

Thermo Fisher Scientific said that it has collaborated with pharmaceutical companies to include a large selection of antimicrobials, enabling access to new therapies for multidrug-resistant infections. Laboratories can also use the system to create their own custom AST plates from more than 300 antimicrobials in broad dilution ranges to consolidate and reduce offline testing, according to the firm.

bioMérieux Highlights Decision-Making Aids: PhenoMATRIX for WASPLab that allows labs to take their automated processes to “the next level” with artificial intelligence and interpretative algorithms for sample interpretation and automated sorting. PhenoMATRIX evaluates growth on a media plate through user-defined custom rules, allowing staff to spend less time reading plates and focus on those that are positive. And its AGILIST advanced analytic platform which securely connects and integrates siloed systems into a single source focused on operational efficiency, antimicrobial stewardship and surveillance, analyzing data in real-time, addressing problems, providing reliable information, and improving communications among key stakeholders.

Raising the Profile of Lab Professionals: Alan Wu, PhD, a professor of lab medicine at the University of California, San Francisco, has a few ideas that he shared with LabPulse.com Editor-in-Chief Emily Hayes at this week’s American Association for Clinical Chemistry (AACC) meeting.  Most laboratory professionals would agree that the public is generally unaware of what they really do. But what’s the best way to change the discipline’s low profile?  Video interview here:  https://www.labpulse.com/index.aspx?sec=nws&sub=rad&pag=dis&ItemID=800269








We have just published our latest report, The World Market for Biomarkers. Biomarkers are biological or biochemical molecules, genetic changes, or other characteristics that can be measured; they indicate or predict a condition, risk, or likely biological response. Biomarkers can be used for a range of diagnostic applications including predicting disease risk, diagnosis, predicting prognosis, identifying appropriate therapy for an individual, monitoring disease or for return of a disease, and other applications. These tests are extremely important, since lab test results inform 60% – 70% of all critical clinical decisions, such as whether to admit, discharge and/or initiate therapy for a patient. Biomarkers are also extremely important in the development of new drugs, as they can be used to generate data that may eventually be part of the regulatory submission package.

The biomarker market is extremely large, reflecting the large market for diagnostic tests based on these biomarkers, and also the ongoing efforts to discovery, validate, and commercialize new biomarkers. This market is fueled by factors that are supporting growth of both the research and the diagnostics markets, including:

  • Aging of the population
  • Rising rates of obesity
  • Growing number of cancer therapies
  • Longer lifespans of cancer patients
  • Advances in technology, improving our ability to analyze the increasing number of biomarkers
  • Advances in bioinformatics

In addition, market growth is being fueled by the identification, validation, and introduction of new biomarkers, and products based on these new biomarkers. These include safety and efficacy biomarkers being used in drug discovery and development, and other applications in addition to diagnostics.

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

Many different technologies have been developed and are used in biomarker discovery, and also for detection and analysis of known biomarkers. These include traditional technologies, some of which have been used for decades. In addition, many new technologies developed for other applications are now being applied in this field. These include mass spectrometry and next generation DNA sequencing. Many tests performed using newer technologies are currently being done primarily as laboratory developed tests (LDTs) or by organizations performing clinical tests for pharmaceutical companies developing new drugs; however, some companies plan to eventually develop IVD test kits based on their laboratory assays. Selected examples of companies using these various technologies are discussed in this report, including key players in the market:

  • Companies Using Immunoassays for Detection and Analysis of Biomarkers
  • Companies with Immunohistochemistry Tests for Detection of Biomarkers
  • Companies Using In Situ Hybridization for Detection and Analysis of Biomarkers
  • Companies Using PCR or Other Nucleic Acid Amplification-Based Technologies for Biomarker Assays
  • Companies Analyzing Gene Signatures
  • Companies Using Microarrays to Detect and Analyze Biomarkers
  • Diagnostics Companies and Clinical Laboratories with Sequencing-Based Biomarkers
  • Companies Using Mass Spectrometry

Companies, clinical laboratories, researchers, and others do not generally purchase “biomarkers.” One exception is in settings in which companies or clinical laboratories acquired rights to use specific biomarkers for certain applications. The application may be development of reagents or assays that can be sold to researchers who are studying the biomarker, or who are using the biomarker in their research. These research applications could include using the biomarker as a safety marker, or as a surrogate marker for clinical efficacy, or a different research application. Alternatively, applications of new biomarkers may be to develop diagnostic assays that will be used in clinical setting for diagnosis, predicting prognosis, monitoring, determining the optimal therapy, or other clinical application. In addition, some biomarkers may prove valuable as potential targets for novel new therapies.

VialsIn our report, the market for biomarkers focuses on the applications of biomarkers. This includes both research and diagnostic applications of biomarkers. The potential market for biomarkers being evaluated as potential drug targets is not included in this market analysis, as that therapeutic market would be determined by the potential market for new therapies targeting the biomarker drug target. Key biomarker categories with 2019-2024 market estimates include the following:

  • Cardiac Markers [cTn, HscTn, Acute CK-MB/BNP, Others]
  • Tumor Markers [PSA, CEA, CA 125, AFP, PSA Rapid, Others]
  • Coagulation Markers [PT/INR, D-dimer]
  • Infectious Disease Markers [including Sepsis]
  • Immunological Disease [Autoimmune/Allergy]
  • Neurological Markers
  • C-Reactive Protein and Other Markers

The World Market for Biomarkers estimates the world markets for biomarkers and biomarker tests from 2014 to 2024, with 2019 as the base year, providing global biomarker market forecasts for the total biomarker market, the market by application (clinical diagnostic biomarker market, research biomarker market), and the market by geographical distribution:

  • Total Global Biomarker Market by Application, 2014 – 2024, in $Millions (Clinical Diagnostic, Research, Total)
  • Biomarker Market Segments by Application, 2014, 2019, 2024, by Share (%) (Clinical Diagnostic, Research)
  • Total Global Biomarker Market by Region 2014 – 2024, in $Millions (North America, European Union, Japan, China, India, ROW, Total)
  • Global Market Segments by Region, 2014, 2019, 2024, by Share (%) (North America, European Union, Japan, China, India, ROW)

The World Market for Biomarkers includes profiles of companies active in the discovery and/or commercialization of biomarkers. This includes companies commercializing in vitro diagnostic tests for detection and analysis of biomarkers, selected diagnostic companies commercializing diagnostic tests in their own CLIA certified laboratories for detection and analysis of biomarkers, and selected other players. The report’s focus is on companies with commercialized products and/or very advanced development programs. The diagnostics market is a highly competitive market, and there are many additional diagnostic companies that offer tests based on biomarkers discussed in this report. Companies profiled in the report range from large, multinational companies to smaller companies in or entering this market, including the following:

  • 20/20 Genesystems
  • Abacus Diagnostica
  • Abbott Laboratories
  • Act Genomics
  • Adaptive Biotechnologies
  • Admera Health
  • Agena Bioscience
  • Agendia
  • Agilent Technologies
  • Alpco
  • Ambry Genetics
  • Athena Diagnostics /Quest
  • Banyan Biomarkers
  • Beckman Coulter
  • Becton, Dickinson
  • Biofire Diagnostics/Biomerieux
  • Biohit
  • Biomérieux
  • Bio-Rad Laboratories
  • Cancer Genetics
  • Caris Life Sciences
  • Cepheid
  • Curetis
  • Exact Sciences
  • Foundation Medicine
  • Fujirebio
  • Genomic Health
  • Hologic
  • Illumina
  • Myriad Genetics
  • Neogenomics
  • Ortho-Clinical Diagnostics
  • Qiagen N.V.
  • Roche
  • Siemens Healthineers
  • Sysmex Corp.
  • Thermo Fisher Scientific
  • Ventana Medical Systems/Roche
  • Zeus Scientific

The large and growing biomarker market has attracted a lot of attention, and new players are entering the market. For biomarkers that have already been commercialized and for which many diagnostic companies offer tests, this is a very competitive field. However, even for companies that have developed their own, proprietary biomarkers, this can be a very competitive market as different companies or laboratories work to convince clinicians to use their proprietary biomarker or panel for a specific disease application, rather than use a biomarker or panel offered by a competing company.

We recently published a customer experience survey.  This blog highlights discusses the report and highlights the major findings of the report, including important recommendations for the clinical diagnostics industry.  For specific vendor performance and user ratings, a purchase of the report is suggested.

Clinical laboratory customers have become increasingly sophisticated and typically have multiple suppliers in every product category from which to choose. Leading diagnostics suppliers seek to differentiate themselves by improving both the tangible and intangible ways they interact with their customers. With the high cost of customer acquisition, the easiest way to increase profitability is to develop one’s current customer accounts. Improving the customer experience through innovation, mass customization and customer intimacy programs is a key strategy many life science companies are pursuing.

Innovation is not limited to developing revolutionary new products. Innovation can also be incorporated in the ways customers find, buy and use your products.

Smart companies continually evaluate customer reactions to multiple touchpoints so that they can offer the kind of experience that inspires customers to want to come back. Diagnostics suppliers will be challenged as to how to get beyond “better sameness” to create truly memorable customer experiences. The question becomes one of how to best to enhance the quality of the customer experience in a remarkably homogenous marketplace.

In our latest report, Benchmarking for 2019: Understanding the Clinical Diagnostics Customer Experience, we asked more than 300 clinical lab professionals to evaluate 21 different diagnostics companies on 18 critical customer touchpoints. Here at Kalorama Information, we have developed a customer experience model for the diagnostics market. Every time a laboratory professional interacts with a supplier in any way, that moment is a customer experience touchpoint and as such, a branding opportunity. The scope of our report spans the pre-purchase, product-usage and post-purchase customer experience over the course of the purchasing life cycle. It is summarized in the following graphic:

The questions we developed to cover each touchpoint were designed to capture the attributes that are valued by clinical lab professionals. Touchpoints encompass the time spent researching products, the selection process and after the sale is made. Within each touchpoint, we asked customers multiple questions to capture the attributes valued by clinical diagnostics customers. These touchpoints encompass the experiences that lead to repurchase and recommendation of clinical diagnostic equipment and consumables.

Purchasing life cycle questions were asked on an 11-point scale (some with a not applicable option) where “Positive” is a rating of 9-10 and “Negative” is a rating of 0 to 6. Performance is calculated using a Net Promoter Score (NPS)-like methodology; that is, Performance = percentage of Positive responses minus the percentage of Negative responses. This provides a respondent-level view of touchpoint performance. Values for every vendor at each touchpoint are compared to an industry-specific average to provide an understanding as to how each supplier is perceived compared to this average. An awareness of the importance assigned to each touchpoint allowed us to create a weighted overall Customer Experience Score for each supplier, as well as establish an industry-specific standard that is used as a benchmark throughout this report.

Awareness of the breadth of a supplier’s product line has the lowest industry average value. This suggests suppliers must continue to invest in resources to fulfill this need for information, a need that is especially acute during the pre-purchase phase of the purchasing cycle. These investments range from user-friendly and intuitive website design, search engine optimization, and the development of comprehensive website content. This will also assist in the Product Selection touchpoint where the industry is clearly under-performing.

Suppliers who focus their customer experience efforts on outperforming the industry’s averages are those who will achieve the competitive advantage and differentiation they seek.

The suppliers evaluated in our report are:

  • Abbott
  • Agilent
  • BD Biosciences
  • Beckman Coulter
  • Bio-Rad
  • bioMerieux
  • Bruker
  • Cepheid
  • DiaSorin
  • GenMark Diagnostics
  • Illumina
  • Luminex
  • Ortho Clinical Diagnostics
  • Quidel
  • Roche
  • Sekisui Diagnostics
  • Siemens Healthineers
  • Sysmex
  • Thermo Fisher Scientific

How did your company compare to the industry average at each touchpoint? The full report contains detailed profiles and comparisons of 21 leading suppliers. In addition, a companion interactive report gives you the ability to filter the data by company, market segment, region and touchpoint to conduct your own analysis and presentations.


Please download our complimentary report summary.