Quidel is the market leader in point-of-care (POC) cardiac markers, according to a recent report from Kalorama Information. Abbott, Roche and Siemens Healthineers and Response Biomedical also are among the top companies. The findings were reported in Kalorama Information’s latest report, Worldwide Market for Point-of-Care (POC) Diagnostics.

Quidel is a market leader in rapid immunoassays and has significant exposure to the POC markets relative to its size and total revenue, according to the report. Quidel acquired the assets of the Triage business from Alere when Alere was acquired by Abbott in October 2017. The panel combines troponin I, CK-MB, myoglobin, B-type natriuretic peptide (BNP), and D-dimer to provide accurate results in whole blood and plasma. Quidel’s first products were dipstick pregnancy tests launched in 1984. Moving from its primary markets in rapid test kits, Quidel has in recent years introduced POC immunoanalyzers and rapid molecular tests to market.

Abbott with its i-STAT system is a leading provider of handheld cardiac marker tests. Siemens Healthineers and Roche compete in the market as well. Response Biomedical is a small company that develops, manufactures, and markets rapid on-site diagnostic tests for use with its RAMP system for clinical and environmental applications. The RAMP system consists of a portable fluorescent reader and single-use, disposable test cartridges.

Diagnostic tests performed outside the central laboratory or decentralized testing is generally known as point of care. Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments, including the workplace, home, disaster care, and, most recently, convenience clinics.

The menu for POC continues to expand. In the past five to 10 years, POC products were developed in the following categories: HbA1c, BNP, whole-blood lactate, D-dimer, and C-reactive protein (CRP).

Moreover, POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. More diagnostic manufacturers have pursued CLIA waiver status for their POC devices and the CE Mark for POC or self-use. At the same time, more decentralized test venues invest in nonwaived rapid tests and instruments. POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care. New technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, a remote caregiver service for consultation, or an electronic medical record.

About Kalorama Information

For more than 30 years, Kalorama Information has been a leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), imaging, biotechnology, healthcare, medical devices, and pharmaceuticals.

There has been a milestone reached in 2019, but not one to celebrate. There are now more cases of measles in the United States than any time since 1992.  1,077 individual measles cases were confirmed as of June 2019, according to the Centers for Disease Control and Prevention (CDC). With doctors less familiar than they once were in clinically detecting a disease that was largely eradicated, IVDs such as immunoassays and molecular tools are fortunately available and effective. Kalorama Information covers infectious disease in our report – Infectious Disease World Market Analysis.

This year Measles virus (MeV) cases have been reported this year in 22 states – Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New York, Oregon, Texas, Tennessee, and Washington. About 71% of people who have gotten sick from measles this year have been unvaccinated, 11% were vaccinated and the rest had an unknown status, according to a recent CDC Morbidity and Mortality Weekly Report. Symptoms include cold, fever, runny nose accompanied by a rash.

“Because of the disease’s decline, many doctors have not recently seen a measles case, and the rash can be confused with a number of other illnesses. So blood tests are useful to confirm whether if a rash is truly measles.”

Measles is not eradicated worldwide, though it is considered so in the United States. Globally, 451,756 suspected measles cases were registered in 2014. In 2013, the WHO estimated the global measles deaths to145,700. There is a tendency to think of measles as a children’s disease alone, but it is a deadly disease due to the immunosuppresion it can cause. It is also highly contagious human. It can result in complications like pneumonia, brain damage and deafness and can be fatal.

When last there was a noteworthy outbreak, In March 1990, a large measles outbreak began in New York City and other cities in the United States with significant unvacinnated populations. Through December 1990, approximately 2500 cases and eight measles-associated deaths were reported. The CDC and the Academy recommend children receive the first routine dose of MMR vaccine at 12-15 months and the second dose at 4-6 years. One dose is about 93% effective, and two doses are about 97% effective.

Normally, doctors can usually diagnose measles based on the disease’s noteworthy rash as well as a small, “Koplik’s spot” a bluish spot on the inside lining of the cheek. Because of the disease’s decline, many doctors have not recently seen a measles case, and the rash can be confused with a number of other illnesses. So blood tests are useful to confirm whether if a rash is truly measles.

Testing for measles is typically immunoassay-based as it is cost-effective. Enzyme-linked immunosorbent assay (ELISA) is normally used to quantify the amount of serum IgG antibodies against measles, mumps, rubella, and varicella-zoster virus. Examples are Roche’s Elecsys Rubella IgM, ELISA Anti-Measles-Virus/IgM test kit from Siemens Healthineers, Microimmune Ltd’s Measles IgM capture EIA. The method is time-consuming and in some cases, the IgM response is not detectable until 3 days after symptom onset. Some molecular tests are also availalble for more immediate detection, Roche MeVA RT-qPCR on the Roche LightCycler 480, QIAamp viral RNA mini kit, Creative Biogene and Fast Track Diagnostics also have products. Where not available, a second IgM test is often used to find late developing MeV.

News of an approval of a biosimilar for a major Roche cancer drug is, we think, evidence that U.S. biosimilars are a growth market opportunity.   At the same time, the approval is a growth limiter for booming cancer drug markets.  Pfizer Inc confirmed Friday that the the FDA approved its biosimilar to Avastin. Pfizer’s Zirabev received approval for the treatment of five types of cancer, including colorectal and lung cancers.

The global market for biosimilar products has grown to be worth $11.4 billion by 2019, adding to the growing strategies of cost savings and improved health outcomes. This according to Kalorama Information’s Biosimilar Market Trends 2019.

Undeniably the top targets for biosimilars are beginning to hit the market. Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan/MabThera (rituximab), and AbbVie’s Humira (adalimumab) will be experiencing the most pressure from biosimilars. Europe is leading the biosimilar charge worldwide. The US is lagging behind due to legal and regulatory issues that continue to plague the industry but is expected to explode in 2023.  Kalorama Information started watching this industry early in 2002 and now a clear growth pathway in the U.S. is seen.

Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biosimilars are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics.

“The global market for biosimilar products has grown to be worth $11.4 billion by 2019, adding to the growing strategies of cost savings and improved health outcomes. This according to Kalorama Information’s Biosimilar Market Trends 2019.

The worldwide prescription generic drug market has stood the test of time and has endured numerous growing pains. However, it has evolved into a formidable and important participant in the complex world of health care. Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process are facilitating bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years.

In 2017, U.S.-based Amgen Inc’s Mvasi was approved by the FDA as the first biosimilar to Roche’s Avastin, which brought in revenue of $6.85 billion to the Swiss drugmaker in 2018.

The 67th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, held recently in Atlanta, Georgia, is a major showcase for mass spectrometry system (MS) introductions. Below are some of the trends evident among the many system launches.

Small is Big

Agilent Technologies introduced the LC/MSD iQ single quadrupole MS, measuring 12 x 18.7 in (305 x 475 mm), and described it as 7 in shorter and 7 in shallower than its predecessor for an over a 50% reduction in size. A smaller size enables stacking with Agilent’s LC systems. The ease of use and smaller size targets chromatography users.

Shimadzu debuted the MALDImini-1, a 55 lb (25 kg), 11.7 x 16.5 in (297 x 420 mm) MALDI digital ion trap MS system. Size benefits include the ability to be located next to the sample preparation space. Performance specs comparable with larger systems include MSn capabilities.

Thermo Fisher Scientific also aimed to reduce size with the new Thermo Scientific Orbitrap Exploris 480, quadrupole-Orbitrap MS, measuring  534 × 763 × 703 mm (21 × 30 × 27.7 in), a quarter of the size of previous Exploris systems, and half the weight at 120 kg (265 lb) (without data system, vacuum rough pumps, and optional items). The system is designed for applications encompassing small and large molecules, with a wmass range of 40-6,000 m/z and the option of up to 8,000 m/z.

A Cell-ing Point for MS

Bruker’s new SpatialOMx solution enabled by the introduction of the TimsTOF flex MS addresses the need to measure both spatial and temporal characteristics of cellular tumors. It combines MALDI imaging with TimsTOF MS capabilities in one system. Applications include investigation of the correlation of RNAseq results with protein expression in the same sample.

Thermo Fisher Scientific highlighted the use of the new Orbitrap Eclilpse Tribrid MS with TMT reagents and synchronous precursor selection-based MS3 technology for single-cell analysis studies. Proteins in a single cell were identified with a subset quantified, providing information on cell type and cell state.

Flexing Functionality

SCIEX introduced the mid-range SCIEX Triple Quad 5500+ LC-MS/MS System–QTRAP Ready, enabling users to upgrade from a triple quadrupole MS system to a QTRAP for linear ion trap analysis and the added capability of MRM3.

Waters’ new SYNAPT XS provides flexibility with 10 acquisition modes, including Waters’ SONAR and HDMSE data independent acquisition modes, as well as multiple inlet options. It is designed to address a range of applications in drug discovery and characterization.

This article is from our partner publication Instrument Business Outlook https://instrumentbusinessoutlook.com/

For more on the Mass Spec market and new products, see our partner publication, SDi, and their latest MS report.

From our partner publication LabPulse.com: New recommendations released June 11 from the U.S. Preventive Services Task Force (USPSTF) continue to strongly advise HIV screening for adolescents and adults, and for the first time they support preventive treatment for those at high risk. The guidance could boost volume for blood tests.

Kalorama Information’s Infectious Disease World Market Analysis can be found here:  https://kaloramainformation.com/product/infectious-disease-diagnostics-world-market-analysis/

The USPSTF, a volunteer group of independent experts that makes evidence-based assessments for disease prevention, published two recommendation statements on HIV screening and preventive treatment in the Journal of the American Medical Association (Vol. 321:22, pp. 2203-2213). The USPSTF’s last guidance on this topic was published in 2013.

The group gave an “A” recommendation to screening for HIV in adolescents and adults between the ages of 15 and 65 years and for all pregnant women. Furthermore, it advised screening for people younger than 15 and older than 65 who are at risk of getting infected.

The USPSTF did not find enough evidence to set screening intervals, but it concluded that “repeat screening is reasonable for persons known to be at increased risk of HIV infection,” including sexually active men who have sex with men, people who inject drugs, and/or those who are involved with commercial sex work.

The USPSTF also released a new strong “A” recommendation for preventive treatment with antiretroviral medication of people at high risk for HIV. The USPSTF advised that this includes men who have sex with men, are sexually active, and meet one of the following criteria:

Has a sexual relationship with someone who is HIV-positive
Does not use condoms consistently during anal sex
Has had syphilis, gonorrhea, or chlamydia within the past six months.
Currently recommended antigen/antibody tests for HIV are highly accurate, with sensitivity ranging from 99.76% to 100% and specificity from 99.50% to 100%, the USPSTF advised.

“Recommended rapid HIV tests have similar sensitivity and somewhat lower reported specificity ranging from 98.6% to 100%,” the task force wrote in JAMA.

A lot of room to improve

The number of new HIV infections has been dropping — down from 41,200 in 2012 to 38,300 in 2017 — but fewer than half of adults in the U.S. have ever been tested for the virus.

“Approximately 15% of persons living with HIV are unaware of their infection,” the USPSTF authors noted. “It is estimated that persons unaware of their HIV status are responsible for 40% of transmission of HIV in the United States.”

Clinicians and healthcare professionals must do more to reach the 15% who are unaware of infection and account for a big number of new HIV transmissions, urged an editorial published online in JAMA Internal Medicine on June 11.

“Fortunately, new HIV tests are faster and more accurate than previous tests,” wrote Dr. Diane Havlir and Dr. Susan Buchbinder, both of UCSF. “At present, the window period between HIV infection and a positive antigen/antibody test result using a fourth-generation test is about 17 days, which can be reduced by nearly a week with HIV RNA testing.”

Havlir and Buchbinder also noted that in 2018, only 17% of the 1.1 million uninfected people who would be eligible for PrEP actually had a prescription at the end of 2018, and more needs to be done to reach certain at-risk groups, such as women, people younger than 25 years, and those who live in states that have not expanded Medicaid insurance. To reach populations at risk, it will be necessary to move beyond facility-based HIV testing, they wrote.

“Public health departments should support community-based models of HIV testing, including mobile and self-testing, and ensure robust partner-notification programs to identify and potentially curtail transmission of the virus,” Havlir and Buchbinder wrote.

Reducing barriers to testing

Dr. Paul Volberding, co-director at the UCSF-Gladstone Center for AIDS Research, told LabPulse.com he is not expecting a big uptick in testing overall as a result of the new USPSTF recommendations. But he hopes there will be an increase in testing of those at higher risk who have been missed to date.

“The main effect will be to reduce any barriers to testing that have allowed some infected persons to still be progressing in disease stage and transmitting to more people,” Volberding wrote in an emailed response to questions.

The change in the USPSTF recommendations follows a call at the highest level of government for an end to HIV. Earlier this year, President Donald Trump pledged an end to the epidemic in the U.S. within 10 years.

Many practical challenges remain, however. Massachusetts General Hospital infectious disease specialist Dr. Rochelle Walensky and Yale University’s David Paltiel, PhD, flagged the lack of attention to economic considerations in the 2019 HIV screening guidance in an editorial in JAMA Network Open.

“Testing for HIV, at about $25 per test, may be cheap, but each case of infection that is detected and successfully linked to care triggers a lifetime of [antiretroviral therapy], costing at least $40,000 annually,” Walensky and Paltiel wrote. “And at an annual cost of $20,000 per person, the drug component alone of a complete PrEP rollout for all those eligible would cost $24 billion annually.”

So while the USPSTF has taken an important step toward the goal of ending the HIV epidemic in the U.S., execution in the most at-risk communities will be crucial, they suggested.

Sign up for www.labpulse.com for breaking news updates.

Liquid biopsies are a set of minimally invasive diagnostic methods that analyze tumor-derived materials that can be found circulating in biological fluids, to provide information for the diagnosis, treatment, and monitoring of cancer. While tissue biopsies and imaging techniques remain the current standards of care in the diagnosis of solid tumors, they have risks and limitations and limitations, some of which can be overcome by the use of liquid biopsy in clinical oncology, as an alternative or complementary technique to the current standards of care.

The market is expected surpass $1.5 billion by 2023, according to our latest report,  World Market for Liquid Biopsy, 2018-2023. 

As of 2019, over 40 companies are active in the global market for liquid biopsy diagnostics and monitoring tests. The market for liquid biopsy testing, still in its infancy, is rapidly evolving as vendors develop and commercialize innovative new technologies to meet the needs of the clinical diagnostic market. Demand is also growing swiftly, at a projected CAGR of 27.9% over the next five years, as patients, clinicians, and payors increasingly accept liquid biopsy as an alternative or complementary procedure to traditional tissue biopsies.

Types of Analytes

Commercially available liquid biopsy tests target three main categories of analytes: circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and exosomes (also called extracellular vesicles). Other analytes that are not a frequently targeted are cell-free RNA species (cfRNA), and proteins.

The most frequently targeted analyte in liquid biopsy is ctDNA, which encompasses small fragments of DNA that are believed to originate from the natural and abnormal necrosis and apoptosis processes undergone by solid tumor cells as well as normal cells during regular cellular turnover. The processes which generate ctDNA are accelerated in tumorigenesis, resulting in a greater abundance of ctDNA in biofluids, such as blood, urine, plasma, and cerebrospinal fluid. However, ctDNA is still found in relatively low concentrations, and has a short half-life in the bloodstream, which makes their isolation and identification challenging. Furthermore, the information that can be derived from ctDNA is limited to genomic sequence. ctDNA cannot provide information about transcription levels, translocations and fusions, or protein expression

The presence of ctDNA may also result from tumor cells killed by therapeutic drugs, and does not capture information about the residual cancer that may not respond to the particular therapy or has become resistant to it.

CTCs are a population of tumor cells that are believed to have detached from the primary tumor or metastatic tumor sites, and are found circulating in blood. CTCs are thought to be a fundamental process in metastasis. Because they are intact, viable cells they have a longer half-life in the circulatory system, and they offer several analytical advantages not possible with ctDNA analysis, including RNA and protein analysis, and intact genome. There are, however, significant challenges in capturing CTCs for analysis. CTCs are rare events and not always present in peripheral blood, even in the case of metastatic cancer patients. When present, their concentration is very low, in the range of one CTC among billions of red blood cells and millions of leucocytes. CTC markers may differ from those of primary tumor cells, and may also change over the course of therapy, making them difficult to target.

Exosomes are nanometer-sized extracellular membrane-bound vesicles secreted by cells to the extracellular environment on a continuous basis by most eukaryotic cells as a means of extracellular communication. They are highly stable in biological fluids, and, due to their miniscule size, can escape filtration by the kidneys to be found in urine, and can pass through the blood-brain barrier. Exosomes contain molecular information from their parental cells, by encapsulating proteins and various nucleic acids such as double- and single-stranded DNA, mRNA, miRNA, and other non-coding RNA. This provides many analytical advantages over ctDNA. However, because exosomes are secreted by most cells, it is difficult to efficiently discriminate and isolate them from other types of extracellular vesicles in bodily fluids. Due to the complex composition of biological fluids, the detection and isolation of high purity exosomes is a long process that imposes the use of multiple techniques based on various parameters.

The development of molecularly targeted cancer drugs is one of the most exciting advancements in oncology. The potential benefits from the identification of drug targets and the associated drugs and tests are illustrated by several novel examples, such as HER2/neu & Herceptin and Gleevec.
The rising incidence of cancer, particularly in the over 50 population, is likely have a significant impact on all areas of cancer treatment; however, for many cancer types, there remains a significant unmet need in effective treatment. Lung cancer is one example, as patient survival is less than five years after diagnosis.

Traditional therapies have failed to provide adequate redress for these patients, signifying a need for an alternative treatment plan. Programs, such as those that grant compassionate use, are becoming more common as provider and patients continue to demand better therapies with the potential for increasing life.

The targeted cancer therapeutics market specifically focuses on five leading segments of targeted therapies: monoclonal antibodies, tyrosine kinase inhibitors, angiogenesis inhibitors, CDK inhibitors, proteasome inhibitors.

Additionally, smaller areas of targeted therapies are covered including mTOR inhibitors, PI3K inhibitors, PARP inhibitors, apoptosis inhibitors, histone deacetylase inhibitors, hedgehog signaling pathway inhibitors and several others.

The use of monoclonal antibodies in cancer therapy is currently the subject of intense investigation. Monoclonal antibodies specifically bind with target antigens and could, therefore, be used in several ways to treat cancer. Antibodies can be used to deliver a cytotoxic drug preferentially to the cancer cell and thus minimize drug interactions with normal cells. Similarly, antibodies can be used to direct other cytotoxic cells, such as macrophages and T cells, to tumor cells lurking in the body. Antibodies can be attached to a radioactive label and injected into a patient to screen for recurrence of tumor growth. Antibodies can also be directed against cells that support tumor growth.

The Advantage of Targeting

Targeted therapy is defined as the use of specific treatments and drugs tailored to each patient and to various types of cancer, in order to stop the spread of cancerous cells in the body with as few side effects or damage to healthy cells as possible. Advances in this field are coming fast and furious, according to specialists, and many new therapies work on a molecular level, using biological agents to stop cancerous and abnormal cells in their tracks.

According to the National Cancer Institute (NIH), targeted cancer therapies are different from standard therapies in the following ways:
• Targeted therapies act on specific molecular targets that are associated with cancer, whereas most standard chemotherapies act on all rapidly dividing normal and cancerous cells.
• Targeted therapies are deliberately chosen or designed to interact with their target, whereas many standard chemotherapies were identified because they kill cells.
• Targeted therapies are often cytostatic (that is, they block tumor cell proliferation), whereas standard chemotherapy agents are cytotoxic (that is, they kill tumor cells).
The problem with many of the “broad” or traditional therapies is that they damage healthy cells while trying to eliminate cancerous cells.

Rising Incidence

As noted, the incidence of cancer is on the rise. In 2018, the International Agency for Research on Cancer reported that more than 18 million people were diagnosed with cancer. Of these, lung, breast, colorectal, prostate, stomach, liver and esophagus were the most commonly reported. Together, these account for nearly 10 million cases.

Worldwide between 40 and 45 million people are living with cancer and nearly 9.6 million people have died. Cancer deaths occur in about 50% of people who develop cancer in developed countries; this is in contrast to 80% death rate in cancer patients in underdeveloped countries. The risk of developing cancer before the age of 75 years is about 20.2%.

These data highlight the importance of effective cancer therapies in the current market; however, as we move toward 2040, the World Health Organization anticipates an increase to about 28 million new cases annually by 2040, a 62% increase over 2018.
Cancer is a disease characterized by uncontrolled cell proliferation. Despite more than 100 different types of cancer, those of the lung, breast, prostate, and colon-rectum account for nearly half of all new cases per year in the United States. Lung cancer, which is highly correlated with cigarette smoking, is responsible for more deaths than any other form of cancer. Cigarette smoking and other environmental factors are associated with the majority of cancers. Major advances in molecular medicine have shed light on the pathogenesis of cancer at the biochemical level.

Top Competitors

The top 15 market participants in targeted therapies, responsible for roughly 97% of targeted cancer therapy revenue, include:
• Johnson & Johnson (J&J)/Janssen
• AbbVie
• Amgen
• AstraZeneca
• Takeda Oncology – Millennium Pharms
• Eli Lilly
• Bayer
• Merck EMD Serono
• Exelixis
• Roche/Genentech
• Celgene
• Bristol-Myers Squibb (BMS)
• Novartis
• Merck
• Pfizer

Results below expectations, perhaps explained by one-time events, were coupled with new product launches and some silver lining in niche markets, as the top two IVD companies announced first-quarter results.  Roche’s Diagnostics division reported sales of $2.9 BN CHF (approx. $2.86 BN USD) and 1% growth, with Molecular Diagnostics as main contributor.  That was flat growth since last year the division grew 5% in the first quarter.

Roche is the world’s largest diagnostic company and its results can speak to the broader market.

The company claimed temporary events and one-time offsets dampened growth, and there were some unusual events in the quarter.  Distributor inventory reduction on point-of-care products in China and one time offsets in tissue diagnostics, also free-of-charge deliveries following the recall of CoaguChek test strips in the fourth quarter.

Within these results, a few events are notable for watchers of diagnostic markets:

  • Roche reported that its molecular Point of Care Sales Up 18%, as cobas Liat finds markets in physician offices and decentralized hospital testing locations.
  • Sales in cervical cancer diagnosis grew 52 percent and sales in blood screening grew 14 percent.
  • While Diabetes care grew 1%, growth was 18% in North America due to recent management care contract wins.
  • While sales in Japan and China were disappointing, EMEA sales were up 3% and Latin America was up 8%.

The company noted several product launches.   The Cobas VivoDx system for antibiotic resistance testing provides results in under 6 hours and can perform 96 tests per 8-hour shift.  NAVIFY mutation profiler combined with NAVIFY therapy matcher both [ph] as a curated knowledge base of genetic fragments to help interpret the clinical significance of the patients and identify suitable therapies. and the VENTANA PD-L1, SP142 Assay, the first FDA companion diagnostic approval for use in first line triple negative breast cancer or TNBC.

Kalorama Information’s Worldwide Market for In Vitro Diagnostic Tests provides market sizing and forecasting for all categories of the IVD market
Now in 11 Editions. 

Abbot Diagnostics grew .2% on a reported basis to $1.8 BN dollars, though currency effects clouded otherwise 4.4% organic growth.    Growth was driven by long-term double-digit growth in its Alinity molecular diagnostic platform and other products.  But due to lower flu test revenues , rapid diagnostic revenues, comprising Alere, which Abbott bought in late 2017, decreased 4 percent to $537 million from $559 million.

New products included a CE Mark for Abbott’s Determine HBsAg2 rapid diagnostic assay. highly sensitive, easy-to-use, rapid lateral flow test enables identification of those with.  And the company received a CLIA waiver for their BinaxNOW Influenza A & B Card 2 assay.



A relatively new disease with particular strength in the New York City area but also in 12 U.S. states has seen 617 cases as of time of writing – with particular strength in weakened patients and those in long-term facilities.  Because the fungus is detectable only with complex lab tests such as mass spectrometry, sequencing and novel PCR, test makers once again have an opportunity to demonstrate products can handle novel pathogen threats.

The fungus — Candida auris, also referred to as C. auris —  is treatable with antifungal drugs called echinocandins. However, some C. auris infections are resistant to the main types of medications.   It is particularly found in hospitals and long-term care facilities.   The most common symptoms of invasive Candida infection are fever and chills that don’t improve after antibiotic treatment for a suspected bacterial infection.  While healthy people do not often get the fungus, the CDC is warning all in such facilities to be vigilant about washing hands after patient contact.

The fungal infection tends to target those with compromised immune systems.  Because these are also patients with serious conditions and existing changes of fatality, as many as half may die when contracting the condition, making isolation and treatment early on a key.

[Note – Kalorama covers mycology testing market sizing and forecasting in its report  Infectious Disease Diagnostics, World Market Analysis ]

The disease has taken a particular statistical bent in the New York City area, where two-thirds of the cases were reported.

The fungal infection is tricky to diagnose, though that opens up an opportunity for mass spectrometry-based IVD systems to contribute to detection during the outbreak.

“Diagnostic devices based on matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) can differentiate C. auris from other Candida species, but not all the reference databases included in MALDI-TOF devices allow for detection,” according to the CDC guidance.

Sequencing-based molecular methods based on sequencing the D1-D2 region of the 28s rDNA or the Internal Transcribed Region (ITS) of rDNA also can identify C. auris.   Other products, such as PCR, can identify fungal infection absent a specific C. auris designation:

T2 Biosystems’  T2Candida® Panel identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days.  The FDA-cleared and CE marked test runs on a desktop analyzer based on magnetic resonance imaging and provides results within five hours.

Thermo Fisher’s RapID YEAST PLUS System, a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like and related organisms which have been isolated from human clinical specimens.  It does not specify C. auris at time of reporting, but can signify candida infection which can suggest further testing.

The CDC also said that laboratories with capability to characterize isolates further when C. auris is suspected are encouraged to do so. Suspected isolates can also be sent to CDC’s AR Lab Network for identification and antifungal susceptibility testing.  This testing is performed free of charge and may require coordination through the State Public Health Department’s Healthcare-associated Infection (HAI) Program.  The CDC advises that Isolates should be submitted on slants shipped at room temperature.   Futher, mycology specific media are not necessary if the laboratory does not have them. C. auris can grow on blood or chocolate agar slants.

In China, reaction to the disease is more stated though cases are also lower and not likely to cause an epidemic in China, according to an article in in China Daily http://www.ecns.cn/news/2019-04-12/detail-ifzhhxra9209972.shtml.  The country’s medical authorities are concentrating on patients with serious disease or undergoing chemotherapy.








Pittcon 2019 now in its 70th year, meets in Philadelphia this week.  The meeting is an opportunity to showcase improvements in laboratory technology.  While mass spectrometry and liquid chromatography are key areas for vendors, this year’s meeting will feature a large demonstration space where vendors will show off spectrometry, software and even analyze common everyday beverages to demonstrate their system features.

Bioinformatics Inc., Kalorama Information and related companies will be present with a large team.  Kalorama Information’s partner publication SDi (STRATEGIC DIRECTIONS INTERNATIONAL)  recently published its 80+ instrument market analysis report, Global Assessment 2019, https://bioinfoinc.com/product/2019-sdi-global-report-analytical-life-science-industry/.  The report covers the bulk of the industry at the meeting.

A few noticeable early announcements are on our radar:

 Bruker Biosciences will exhibit a new inert gas fusion (IGF) analyzer.  The new G6 LEONARDOTM is an economic, robust and precise inert gas fusion (IGF) analyzer for oxygen, nitrogen and hydrogen (ONH) concentration measurements in inorganic samples.  With its pre-calibrated standard methods and argon gas instead of helium, the G6 LEONARDO addresses the needs of industrial process and QC for easy and cost-effective operation.

Bruker also announced a new software acquisition intended to help manage pharamceutical projects.  Bruker announced that it has acquired Arxspan LLC , a provider of cloud-based scientific software and workflow solutions. Arxspan is known for its line of cloud-based products for the management of research data, with a focus on serving pharmaceutical and biopharma customers.

“Known-Knowns” and “Unknown-Unknowns”

Among many other show developments and announcements, Thermo Fisher Scientific will host two seminars dedicated to small-molecule.  The company will inform attendees of its new software solutions coupled to a new Orbitrap HRAM mass spectrometer to tackle the challenge of capturing sufficient, high-quality MSn fragmentation spectra for each component within complex samples. The company says these new solutions revolutionize the process and effectiveness of confident compound characterization of known-knowns, known-unknowns, and unknown-unknowns.

In another seminar, Thermo will feature New dual-LC technology and single-quadrupole MS provide opportunities to increase throughput by analyzing samples more efficiently and reduce operational costs by optimizing bench space. Learn how these systems can be used for efficient characterization of (bio)pharmaceuticals, fast method development, and comprehensive separation and detection of complex samples.  The Vanquish Duo for Dual LC houses two flow paths in one system to save space and improve returns.

Waters Corp. will demonstrate it’s Automated PeakTracker in Fusion QbD for Advanced LC and LC/MS Method Development a new platform that dramatically advances chromatographic method development:   Waters Empower CDS with Fusion QbD® Software containing PeakTracker™, the Waters ACQUITY H-Class PLUS UPLC, PDA detection, and ACQUITY QDa Mass Detector.

The company says that PeakTracker is a new automated peak tracking technology that optimizes and simplifies mass detection in the method development workflow. Complex separation challenges addressed includes.  Partially co-eluted peaks assigned the same mass, Completely co-eluted peaks resulting in missing data.

“Beverage Identification” on Display

 Waters is hosting a “Kool Aid Never Looked So Good” Separation Challenge to test sample preparation skills on the exhibit floor Thursday.  Participants will be given two “mystery” samples and some clues about the products. Using solid-phase extraction, they will guess the food dyes, order of elution and complete a separation in less than one minute.   Judging will be based on the accuracy of your guesses and the performance of separation.

PITTCONN Philadelphia will boast two live demo areas where attendees can participate in 20-minute, interactive product demonstrations. The dedicated areas will cover topics such as air monitoring, new techniques in water testing, innovative products to increase lab efficiency, and recent developments in spectroscopy, spectral databases, and techniques for using hazardous materials.  Among the events at the  “Live Demo” areas include:

  • Is your coffee really decaf? Lumex Instruments will test that, using capillary electrophoresis technology.
  • Trajan Scientific and Medical will demonstrate its two automated systems for performing Liquid-Liquid extractions [LLE] on a micro scale. They can be applied as effective alternatives to the time-consuming manual processes
  • Sartorius will exhibit its “Next-Generation” balances for high performance lab use.  Balances feature a 0.1 mg resolution at 64 g, 124 g, or 224 g. capacities.  Each is available with or without an internal calibration weight.
  • Shimadzu Scientific Instruments will display its Elemental Analysis: EDX-7000 X-ray Fluorescence Spectrometer Bench-top energy dispersive X-ray fluorescence instrumentation can provide a safe, fast and easy alternative to more difficult and expensive technologies like Atomic Absorption (AA), Optical Emission Spectroscopy (ICP-OES) and Mass Spectrometry (ICP-MS).
  • Bio-Rad Laboratories will demonstrate its Bio-Rad’s KnowItAll® Solutions, combining  IR & Raman spectroscopy with spectral analysis software
  • HORIBA Scientific will demonstrate in nanoparticle identification, quantification, and sizing by nanoparticle tracking
  • Cerno Bioscience will present its GC/MS Compound ID Using Accurate Mass and Automated Mixture Detection