This infographic is based on the report The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, AutoImmune, Others) by leading medical market research publisher Kalorama Information. Purchase the report for more insights on the past, present, and future of this important market.

 

The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, AutoImmune, Others)

Over the years, the increasing introduction of transportable, portable, and handheld medical instruments has resulted in the migration of point-of-care (POC) testing from the hospital environment to a range of medical and non-medical environments including the workplace, home, disaster care and most recently, convenience clinics. In the face of the ongoing global COVID-19 pandemic, the reliance upon and need for testing without the direct involvement of healthcare professionals has become arguably more important now than ever before, according to Kalorama Information in the new report At-Home Testing: COVID-19 Trends and Future Potential.

Rapid tests to detect the presence of the coronavirus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19, even with vaccines readily available.  There are now FDA-authorized COVID-19 tests sold online and in stores that can be used completely at home.  At-home tests allow individuals to collect their own sample and test it with a system that gives results in minutes at home.

It’s been more than one year since the world was thrown into the chaos of the COVID-19 pandemic.  One thing that has become apparent is that early diagnosis is crucial to prevent the spread of such infectious diseases throughout a community.  Rapid diagnosis, such as what is offered through at-home testing, is also key to containing outbreaks by allowing for efficient contact tracing in communities.

In many situations, POC and self-testing at home are tools to overcome roadblocks in testing due to sampling issues and testing delays.  Self-collected samples and home tests are provided by a growing number of hospital and independent laboratories to expand the network of testing options in all major markets in North America and Europe.

Home self-testing is not new: pregnancy tests, urine screening dipsticks, and glucose monitoring products are readily available in pharmacies and retail outlets in various major markets worldwide.  Consumers also make online purchases of kits marketed for STIs, HIV, allergies, vitamin D, food sensitivity, ancestry, and DNA testing.  These kits generally involve the collection of cheek swabs and saliva specimens that are then sent to a laboratory for processing.

From a public health perspective, at-home self-tests can offer advantages when used to complement professionally administered rapid tests or lab-based tests.  They can improve the accessibility to testing.  They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.

Despite the apparent positives, the home-based rapid tests for infectious diseases are a work in progress and have their share of critics. Naysayers contend that preanalytical problems often surface with self-collection methods and home tests that can put patients at risk.  While home sample collection kits are designed to be simple, problems commonly occur with self-collection that can affect the quality of the sample and, therefore, the subsequent test result.

Nevertheless, from a public health perspective, self-tests can offer advantages when used to complement professionally administered rapid tests or lab-based tests.  They can improve the accessibility to testing.  They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.

Self-testing with over counter (OTC) and direct to the consumer (DTC) kits could therefore enhance disease control with efficient identification and isolation of cases. However, there again are potential disadvantages, as shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting, and make response measures such as contact tracing and quarantine of contacts challenging because the test results do not enter a government database.  Current indicators for monitoring the intensity and spread of the COVID-19 pandemic such as testing rates, test positivity rates, and case notification rates, could be affected, and could make it difficult to monitor disease trends over time.  An additional challenge is that samples from self-testing would not be available for viral sequencing and monitoring variants.

For more information on these and other topics related to this market, purchase At-Home Testing: COVID-19 Trends and Future Potential by Kalorama Information at: https://kaloramainformation.com/product/at-home-testing-covid-19-trends-and-future-potential/.

At-Home Testing: COVID-19 Trends and Future Potential

Rapid tests to detect the presence of the virus at the point of care, which are faster and cheaper, are a vital addition to the testing arsenal needed to contain and fight COVID-19.

Total global sales of biomarker test products are projected to reach nearly $63 billion in 2027 with the majority of sales coming from the United States, Western Europe, and Japan, according to new data by leading medical market research publisher Kalorama Information in the report The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, Autoimmune, Others). This amount will correspond to a 5.5% annual gain from levels in 2018.

Biomarkers include more than 1,000 substances that serve as reagents, consumables, and/or test components for several medical-related diagnostic and research applications.  Substances that detect and measure genetic changes in patient samples are also included in Kalorama Information’s sales estimates.  The global market for biomarker products is led by large multinational in vitro diagnostic (IVD) companies, including Abbott Diagnostics, Becton Dickinson, bioMérieux, Bio-Rad Laboratories, Danaher, Hologic, Ortho-Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific.

Specific uses of biomarkers include:

  • detection of human diseases and disorders
  • identification and selection of appropriate therapies for diagnosed conditions
  • monitoring of disease progression
  • monitoring of the effectiveness of selected therapies
  • detection of disease relapse or recurrence
  • evaluation of new drug candidates as to safety and effectiveness

Of the seven major segments of biomarker products, infectious diseases will account for the largest share of worldwide sales over the long term.  Revenues in this segment will continue to rise due to the emergence of new disease threats, an increasing number of conditions attributable to aging demographic patterns, and the expanding availability and use of high value-added molecular tests.

Applications in cancer testing, staging, and treatment assessment will comprise the second-largest segment of biomarker products based on global sales in 2027.  Moreover, this segment will post the fastest worldwide revenue growth for biomarker products as the number of cancer patients continues to rise and medical providers upgrade capabilities for cancer testing, screening, monitoring, and therapy selection.  New products based on liquid biopsies, next generation sequencing, and other advanced technologies will also serve to boost global sales of cancer biomarker products.

Other conditions and applications that will generate sales growth for biomarker products include:

  • Cardiovascular diseases, which are the leading cause of death worldwide. Reagents, test kits, and consumables for the detection of coronary artery disease, high cholesterol, and congestive heart failure will command the largest share of revenues.
  • Applications in regular patient physical examinations and pre- and post-hospital admission testing, which will see gains but will generate comparatively slow revenue growth due to competition from more sensitive molecular and rapid point-of-care (POC) tests.
  • Biomarker products for neurological and autoimmune conditions will expand favorably as medical providers seek to improve testing and monitoring capabilities for increasingly problematic conditions such as Alzheimer’s disease, degenerative nerve and muscle disorders, Hashimoto’s thyroiditis, and inflammatory bowel disease.
  • Inherited diseases, which will generate fast revenue growth among other biomarker product applications as advances in molecular technologies leads to the introduction of new, high value-added genetic tests.

For more insights on this market, purchase Kalorama Information’s The World Market for Diagnostic Biomarkers (Tumor, Cardiac, Infectious Disease, Autoimmune, Others)

The world market for in vitro diagnostics will reach 83.3 billion dollars in 2020, when the molecular and antibody sales of COVID-19 testing is considered.   This is according to our latest report, The Worldwide Market for In Vitro Diagnostics, 13th Edition, due out August 26th.

Molecular diagnostics, for the first time in Kalorama Information’s two-decade history of covering the market, will represent more than 15% of the market, double where the category fell in 2019.  This reflects not only PCR tests for the virus, but also the continued use of molecular for new purposes such as prenatal testing and cancer marker detection.

Under any circumstances IVD  was set to grow in 2020.  Testing had been making headway over the last decade.  New product introductions, investments and mergers were brisk.  Tests for cancer and infectious disease detection, transplant success, pharmaceutical selection have added healthcare value and improved outcomes.  Genetic tests for rare diseases and prenatal assessment are increasingly  utilized.

On top of these developments, the COVID-19 pandemic has highlighted how important testing is in a way that could not be imagined.

Kalorama’s report, published for two decades, is the result of careful study of company filings and releases, government information and modeling by seasoned market analysts. Instruments, reagents and associated purchases are included.  The report breaks out the market by category -from standard clinical chemistry tests to immunoassays, to advanced molecular testing and histology tests for cancer detection and treatment selection.

The report said that growth areas outside of COVID-19 testing were tests for other respiratory pathogens, critical care tests such as blood gas and sepsis markers, immunoassays for infectious diseases and point of care tests.  Areas affected by COVID-19 and resulting social distancing were diabestes tests, cancer tests and inherited disease, though the report indicates that some catch up revenues will be experienced by in vitro diagnostic companies later in the year.

COVID-19 has affected every diagnsotic company. This had dominated the activities of players such as Roche and Abbott, specialists in respiratory testing such as BD and Quidel, and international testing companies such as Seegene, SD Biosensor and DiaSorin. Life Science companies with diagnostic offerings such as Thermo Fisher Scientific and Illuminia have also developed test kits and have seen changes from the pandemic. Some test categories that are not related to COVID-19 have suffered as the pandemic closed hospitals to surgeries and decreased in-person visits with physicians greatly. All of these factors have been considered in Kalorama Information’s analysis.

While this is happening, various worldwide payor schemes are pressuring prices. The response is consolidation of lab operations and facilities. Same with IVD vendors. Consolidation remains the rule in the industry among both customers and vendors. The majority of the market is from a score of companies. Part of this development is related to organic company growth but also to strategic acquisitions that add revenue streams and product innovations.

Still, the report details, there is a multi-billion-dollar opportunity for other entities. Beyond the market numbers, the pace of mergers and acquisitions is brisk. Investor interest in IVDs is high. Their role as a gateway to pharmaceutical markets and healthcare provision markets is significant. And IVDs tie with stents as the most frequent type of medical device submitted to the FDA for new product registration. All of these suggest a dynamism in the market.

IVD is a global market this year as much as anything else. The regional figures in the report have not yet been published, but last year Kalorama said 58% of the market is now outside of US. Developed markets (N. America/Europe/Japan) still make up the bulk of IVD sales but growth is dependent on developing nation IVD markets. Among these markets are China, India, Korea, Turkey, and Brazil but IVD vendors are finding new emergent nations, like the Philippines at 9% revenue growth or Malaysia, with 8% growth.  With COVID-19, more testing volume has returned to the United States, at least near-term. Wed now project that ratio to be 55% non-US, 45% US.

US vs. Non-US Share

Growth areas outside of COVID-19 testing were tests for other respiratory pathogens, critical care tests such as blood gas and sepsis markers, immunoassays for infectious diseases and point of care tests. Areas affected by COVID-19 and resulting social distancing were diabetes tests, cancer tests and inherited disease, though the report indicates that some catch up revenues will be experienced by in vitro diagnostic companies later in the year.  Despite some loss in volume due to social distancing, areas like liquid biopsy and automated histology remain promising technologies long term.

Leading companies in IVD include Abbott, Siemens Healthineers, Roche, Danaher (notably Cepheid and Beckman Coulter), bioMerieux, Ortho Clinical Diagnositcs, Bio-Rad, Sysmex and Hologic. The COVID-19 crisis has focused attention on firms such as Quidel, Seegene, DiaSorin, BGI and several other firms that were already competing in the market but launched competitive tests for COVID-19 and related areas.

The Worldwide Market for In Vitro Diagnostics, 13th Edition is now availalble for pre-orders: https://kaloramainformation.com/product/the-worldwide-market-for-in-vitro-diagnostics-13th-edition/

Lab-developed tests were controversial before the COVID-19 pandemic, and there was attempts at regulating them more in the United States.  Then came a massive infectious disease threat for which lab developed tests were essential.  The sudden onset of a disease for which there were no existing test products, so labs had to develop their own.

Lab-developed tests are likely to be a fifth of tests, according to a recent survey by the Association for Molecular Pathology.

There has been a running stalemate under the role of laboratory-developed tests, which may or may not change in the wake of COVID-19.  Originally, LDTs were designed to be solutions that do not otherwise exist yet on the market. Hence, FDA has not enforced premarket reviews of LDTs. Instead , LDTs are regulated by the Centers for Medicare and Medicaid Services (CMS), where they are categorized as high- complexity tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). However, technology advancements have facilitated designing of complex LDTs, with some being similar to IVD tests that have undergone FDA review before entering the market.

The majority of LDTs are based on molecular diagnostic technologies such as nucleic acid amplification, array-based hybridization, NGS, and liquid biopsies.

Could COVID-19 break the stalemate towards the side of test innovation and LDT?  Lab Developed Tests were critical for the crisis in late march. For instance there were media reports  January that SARS-CoV-2 virus had reached the US, lab professionals said they were hesitant to launch LDTs. They were unsure if the agency would practice “enforcement discretion.”

One showdown proved ill-timed for the side of stricter FDA regulation of tests.   In March 2020, lawmakers introduced a bill that would vastly change the oversight system for diagnostics in this country and give the US Food and Drug Administration explicit authority to regulate tests developed by labs, legislators and media were confused by what seemed to be a reversal of need for more testing.    The bipartisan (VALID) Act was designed to streamline regulations and speed access to tests in public health emergencies like the present COVID-19 pandemic.

  Opponents argued that in the hands of the FDA, the lab industry would be overburdened with regulation and no longer nimble in the face of advancing science or a sudden public health crisis.

Kalorama Information produces 30 reports a year.  Their reports can be found at www.kaloramainformation.com

The landscape of COVID-19 testing has been rapidly evolving.  New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods.  With the sudden global demand and governments loosening requirements during the crisis, there has been an unprecedented flood of products.  It has attracted scores of companies, some of which have rushed or cut corners and produced tests with low accuracy.  In many cases there have been recalls and the FDA has issued warning letters, revoked EUAs, and tightened some of its more lenient regulations, for example for Policy D antibody tests.

Along with labs procuring additional systems and increasing their staffing, there are other ongoing activities that are being undertaken to address the various challenges of COVID-19 testing.  The growth is expected to continue, even with some areas seeing declining cases for example in the US.  Most labs are using multiple suppliers’ COVID tests, as a way to hedge against shortages or other problems.

A significant but decreasing portion of countries still remains relatively unscathed with small numbers of cases.  There are only about 40 countries with zero to one case per day, out of 210, mainly islands or less-travelled areas.  Regions that are seeing their first spike in cases are now facing the issue of scaling up to the necessary volume.  Due to the unknowns that remain about the virus, it is also still a challenge to determine the appropriate level of testing.  Some lessons can be applied from the countries that were hit earlier

This is partly dictated by the existing instrumentation but there is usually some flexibility.  Pooling and other techniques are being incorporated to stretch supplies out for more tests.

Due to the supply situation as well as the nature of scientific collaboration, many professional organizations have taken the initiative to address the challenges.  The Association for Molecular Pathology (AMP), for example, has developed five key recommendations for testing labs to best respond to the pandemic, based on its recent survey –

 

  • Reassess type and location of SARS-CoV-2 testing services needed – better match to the situation
  • Reprioritize supply allocations based on clinical testing needs, which could change over time – e.g. as prevalence falls or climbs
  • Increase transparency, communication, and real-time transmission of information between laboratories and suppliers (commercial manufacturers and government) – reagent, supply, resource availability and supply quantities, allocation strategies etc
  • Real-time coordination amongst laboratories to leverage moments of excess capacity – share supplies to ensure rapid processing of samples
  • Standardize agency reporting format and processes for reportable infectious diseases during a pandemic – reduce significant burden on labs, reduce delays, establish electronic systems and formats.


For countries that are still at the beginning of the crisis, taking these steps could improve the chances of success; and for the others, they will likely be among the key considerations to prepare for the next pandemic.

Companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. The COVID-19 pandemic has gripped the world and continues to be a major area of research and development for diagnostic test developers.

Several approaches continue to evolve, including the use of personalized medicine technologies being adjusted to address the COVID-19 need.

Spartan Bioscience developed its CE and FDA approved DNA analyzer to detect risk of poor treatment choices for patients taking various antiplatelets, antidepressants and PPIs.  People carrying CYP2C19 mutations can impair drug metabolism and alter response to drug therapy.  Over the first-half of 2020, Spartan Bioscience has shifted its technology to focus on detecting COVID-19 and Legionella using its qPCR on-site DNA analyzer.

Our report on companion diagnostics (https://kaloramainformation.com/product/companion-diagnostics-in-the-covid-19-era/), and found that COVID-19 has had a small impact on the market for important cancer test and drug combinations.  But since the oncology therapeutics these tests help facilitate are critically important for patients, that impact was limited.  This was according to informal surveys of companion diagnostic vendors conducted by the authoring analysts of the market report.

Along with new developments, diagnostic service providers are also shifting workloads to address the demand for COVID-19 services.  MiraDx, for example, has opened its CLIA-certified lab to providing COVID-19 test services.  The lab has an analyze capacity of over 9,000 tests with no backlog, reported by MiraDx.  The company also reports test results are available in approximately 48 hours and are being prioritized for hospitals, essential workers and field-based healthcare workers.  MiraDx lists the test at $150 per completed test.
Minimal Ongoing Disruptions

Analysts contacted some oncology treatment centers and others focusing on CDx activity to determine the impact of COVID-19 on laboratory activity.  The analysts of the report found.

• Initial (March 2020) decline in CDx requisitions, yet by April 2020 this was largely resolved;
• Less than 10 percent reduction in test volume reported;
• Budgets largely frozen, no capital expenditures will be initiated in the foreseeable future;
• Some backlog on processing tests due to restructuring of hours and laboratory layout requirements; and
• By appointment only lab draws were in effect beginning around February 2020 for some facilities and ongoing through April 2020 which impacted test volume slightly.

Delaying treatment in patients with overall good prognosis would be detrimental to the outcome in some patients prescribed targeted therapies, primarily cancer therapies.  Therefore, oncologists report only minimal delays in treatment which is often determined case-by-case, dependent on factors such as disease status, cancer type, age of the patients, etc.

For example, systemic therapy may be delayed for a short period in patients aged 50 or older with non-aggressive tumor types; in contrast, delaying treatment in an aggressive tumor could be catastrophic to the patient’s outcome.  The National Institutes of Health (NIH) lists more than 200 clinical trials currently underway for COVID-19 biomarker discovery, development and clinical application.

Along with new developments, diagnostic service providers are also shifting workloads to address the demand for COVID-19 services.  MiraDx, for example, has opened its CLIA-certified lab to providing COVID-19 test services.  The lab has an analyze capacity of over 9,000 tests with no backlog, reported by MiraDx.  The company also reports test results are available in approximately 48 hours and are being prioritized for hospitals, essential workers and field-based healthcare workers.  MiraDx lists the test at $150 per completed test.

There is also a growing trend for treatment centers, specifically cancer treatment centers, and research hospitals to get involved in the COVID-19 recovery plan.  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University (Baltimore, Maryland, United States) is gearing up to commence a Phase II trial to promote recovery from COVID-19 with ivermectin or bicalutamide endocrine therapy.  The study is an interventional trial with an estimated enrollment of 60 participants that have had a confirmed PCR test of COVID-19 infection and require inpatient hospitalization due to COVID-19 with minimal or no respiratory symptoms. Estimated start date is June 2020 with estimated completion in June 2021.

 

In Kalorama Information’s Emerging Infections Testing report (https://kaloramainformation.com/product/emerging-infectious-disease-diagnostics-markets-and-trends/) , we discussed Chagas.  Chagas disease is named after the Brazilian physician Carlos Ribeiro Justiniano Chagas, who discovered the disease in 1909. Chagas disease (Trypanosoma cruzi, known as kissing bugs) is also referred to as American trypanosomiasis. It is endemic throughout Mexico, and Central and South America, and is caused by the protozoan parasite T cruzi, which is transmitted to humans by blood-sucking insects of the family Reduviidae (Triatominae).  Now there is word  that the Defense Department is concerned enough to embark on a study, which is just the latest indication of the disease threat in the United States.

Chagas disease is part of the trypanosomal group of diseases that includes human African trypanosomiasis (also known as African sleeping sickness), and leishmaniasis. These diseases are grouped together because they share a common family of vectors: African trypanosomiasis (Sleeping Sickness, caused by Trypanosoma brucei), South American trypanosomiasis (Chagas Disease, caused by Trypanosoma cruzi), and leishmaniasis (a set of trypanosomal diseases caused by various species of Leishmania).

Chagas represents one of the greatest and least publicized public health problems in Latin America. Transmission occurs through insects that spread in low-income rural and peri-urban housing and through uncontrolled blood transfusions.

Although mainly a vector-borne disease, Chagas disease can be acquired by humans through blood transfusions and organ transplantation, congenitally (from a pregnant woman to her baby), and through oral contamination (foodborne).

Chembio, Bioconcept and Altona Diagnostics are among the companies that produce tests for Chagas.   Last year, a study found that a combination of marketed rapid point-of-care (POC) diagnostics was useful in screening for Chagas disease in a study conducted in Bolivia. The results compared well with the gold standard enzyme-linked immunosorbent assay (ELISA) approach, which is a challenge in low-resource settings, researchers reported on December 19 in PLOS Neglected Tropical Diseases.  Molecular testing is the most effective technique, however it is not widely available for screening programs. There is some expectation that current advancements in miniaturization may lead to cost-effective molecular devices. In the meantime major health organizations have been motivated to take action.

Doctors in the United States that treat people with Chagas disease, a parasitic illness transmitted by the “kissing bug” in the Americas, are increasingly worried about the estimated 30,000 to 45,000 people that are at increased risk of complications from COVID-19 because they have Chagas-related heart problems. As an indication of that concern, the U.S. Department of Defense has granted 700,000 to Texas State University to conduct a study assessing the threat of Chagas disease to military bases. https://www.sanmarcosrecord.com/news/texas-state-university-study-chagas-disease-threat-military.

 

The fast spread of COVID-19, a respiratory condition, has healthcare systems focused on other diseases that could spread using the same method.  Kalorama Information’s Emerging Infectious Disease Diagnostics report: (https://kaloramainformation.com/product/emerging-infectious-disease-diagnostics-markets-and-trends/) details multiple types of viruses that are being tracked worldwide, many that have jumped from developing nations to developed ones.  These are some of the known infectious disease threats, and there is the possibility there could be unknown pathogens as well.

Streptococcus pyogenes (group A streptococcus, GAS) colonizes the throat or skin and is responsible for a broad spectrum of diseases that range from simple and uncomplicated pharyngitis and skin infections (impetigo, erysipelas, and cellulitis) to scarlet fever and life-threatening invasive illnesses including pneumonia, bacteremia, necrotizing fasciitis, streptococcal toxic shock syndrome (TSS), and sequelae such as acute rheumatic fever, reactive arthritis and glomerulonephritis.

Chlamydia pneumoniae [unrelated to the sexually transmitted disease] can trigger pulmonary infections.  Prevalence in the general population is high, reaching up to 70%.  Asymptomatic progression of an infection with Chlamydia pneumonia is often problematic because a primary infection may not be diagnosed until it has led to chronic conditions like asthma or chronic obstructive pulmonary disease.

Acute pharyngitis or Strep throat is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States.

Respiratory syncytial virus (RSV), which causes infection of the lungs and breathing passages, is a major cause of respiratory illness in young children.

“These are some of the known respiratory system-based infectious disease threats, and there is the possibility there could be unknown pathogens as well.”

Bordetella pertussis is the microorganism that causes the whooping cough; a very contagious infectious disease worldwide spread that affects mainly children aged 0 to 4.  Whooping cough was once a terrible menace to children, with hundreds of thousands of cases reported annually.  Then a vaccine drove cases down, and the illness became thought of as rare and even antiquated.  But it never totally disappeared; in 2018 the World Health Organisation reported 151,074 pertussis cases globally.  Based on 2008 data the WHO estimated that there were 89,000 deaths.

Discovered in 2001, human metapneumovirus (HMPV) shares many symptoms with the flu.  Research has shown that HMPV is one of the most common causes of acute respiratory infections.  For otherwise healthy children and adults, it tends to be a minor illness, but can be serious for populations including the very young, the very old and people with underlying health problems, such as asthma or chronic heart disease.

Besides respiratory conditions, diarrheal disease, also known as gastroenteritis (GI), affects approximately 1.7 billion people each year and is a leading cause of child morbidity and mortality worldwide and especially in developing countries. In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations and 17,000 deaths.  Shiga toxin-producing E. coli are commonly associated with food- and water-borne outbreaks of diarrheal illness.  E. coli O157 is the most well-known strain and has been responsible for numerous outbreaks.

These diseases and others are a continued focus of development for in vitro diagnostic manufacturers.

The FDA approved BioFire FilmArray COVID-19 test, as well as Mesa Biotech’s Accula.  Both can bring a COVID-19 diagnosis to the point of care where testing is most needed.   BioFire’s Film Array has thousands of placements.  Accula is a hand-held test.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Tests approved with an EUA include:

  • Mesa Biotech Inc. Accula SARS-Cov-2 Test
  • BioFire Defense, LLC BioFire COVID-19 Test
  • Cepheid Xpert Xpress SARS-CoV-2 test
  • GenMark ePlex SARS-CoV-2 Test
  • DiaSorin Molecular LLC Simplexa COVID-19 Direct assay
  • Abbott Molecular Abbott RealTime SARS-CoV-2 assay
  • Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR
  • Quidel Corporation Lyra SARS-CoV-2 Assay
  • Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test
  • Primerdesign Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
  • Hologic, Inc. Panther Fusion SARS-CoV-2
  • Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit
  • Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2