Kalorama Information will be at the 2019 American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo in Anaheim, CA, with our analysts, gathering market insights and reporting from the meeting.
Some of the many developments we'll be looking for are described below.
Molecular point of care
Polymerase chain reaction (PCR) systems at the near-patient level are among the more innovative technologies in IVD. The market for PCR and other nucleic acid amplification tests at the point of care is worth more than $400 million, according to Kalorama Information's report on point-of-care (POC) molecular diagnostic tests. But how far have systems progressed? How are sales? And where are we with new CLIA-waived tests? Abbott, Cepheid, BioFire (BioMérieux), and Roche lead in this segment, but Quidel, Meridian, Mesa Biotech, and Biocartis are among those with offerings as well.
Given laboratories' role in catching this critical disease, it's not surprising to see a focus on sepsis at this year's AACC meeting. We are most interested in support for/findings on the use of procalcitonin (PCT) as a biomarker, new PCT test products, and progress on new sepsis biomarkers. The meeting features several sessions and exhibit hall demonstrations related to this topic. On August 6, an exhibit hall theater presentation supported by Thermo Fisher Scientific will address the use of PCT as a tool for antibiotic stewardship in hospitals. BioMérieux, Diazyme, iCubate, Nova Biomedical, Response Biomedical, Vitro, and Joinstar Biomedical Technology are among the companies with sepsis products at the meeting.
Our ears will be open for commentary from laboratorians, presenters, and vendors on a recent study published in the Journal of the American Medical Association that found there are at least four clinical phenotypes of sepsis -- with different demographics, laboratory values, and patterns of organ dysfunction. The study was based on an analysis of electronic health records (Seymour et al, JAMA, May 28, 2019, Vol. 321:20, pp. 2003-2017).
High-sensitivity cardiac troponin markers
We'll be on the lookout for discussions, new menu adds, and new analyzers and tests for high-sensitivity troponin markers. The high-sensitivity troponin T (hs-TnT) assay is one of the fastest growing markers in terms of test revenue, according to Kalorama's latest report on the world market for biomarkers.
Of note is Roche's workshop on Wednesday, August 7: "From the Lab to the Emergency Department: The Benefit of hsTnT in the U.S. Since 2017." Nam Tran, PhD, director of chemistry and toxicology in the department of pathology and laboratory medicine at the University of California, Davis, is set to share his center's experience with hs-TnT for improving chest pain assessment, emergency department efficiency, compliance with quality measures of the U.S. Centers for Medicare and Medicaid Services, and resource utilization. Other vendors with marker-related products include: Intekbio, Nvigen, Polymedco, Precision Biosensor, Response Biomedical, Seasun Biomaterials, and Seegene.
Attention to RNA and its potential for diagnostics is on the rise. Kalorama counted more than 120 AACC expo vendors with RNA in their listing, including ELITech, Ximedica, Seegene, Roche, Promega, Idex, Eurofins, Hologic, Bio-Techne, and Becton Dickinson. We'll be looking for discussions or product launches related to RNA-based diagnostics for the detection of gene fusions and differential expression of known disease-causing transcripts. RNA-seq, a method for high-throughput sequencing of RNA molecules extracted from cells or tissue, has several clinical applications, including the detection of disease-relevant aberrant gene expression, gene fusions, and expressed sequence variants.
A recent AACC webinar covered developments in the space.
Antibiotic resistance detection
We expect many offerings in this area and for IVD's role in testing to be a topic of discussion. Abbott's ID Now said its assay can provide results in 13 minutes or less, with positive results available in about five minutes. Streck's new line of CE-Marked antibiotic resistance monitoring and detection kits is now available for European markets. The kits are multiplex real-time PCR reagents for detecting more than 450 beta-lactamase gene targets
Given the unfortunate incident rates and the severity of diabetes, this is an important area for test innovation. The American Diabetes Association (ADA) has revised its standards of care for diabetes since the last AACC annual meeting, so there may be an increased focus by vendors on new hemoglobin A1c (HbA1c) testing systems. The annual joint meeting of the National Glycohemoglobin Standardization Program and the International Federation of Clinical Chemistry and Laboratory Medicine Manufacturer Forum will take place on Monday, August 5, at the Hilton Anaheim.
Vendor activity is expected to be robust. EKF Diagnostics will display its U.S. Food and Drug Administration (FDA)-cleared glycated albumin test, which is 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 will offer several seminars at the meeting related to diabetes, including one on regulatory requirements and legal consequences of off-label glucose testing.
Roche will promote its Accu-Chek Inform II system, which the company said provides results in five seconds.
NAFLD and NASH
Nonalcoholic fatty liver disease (NAFLD), in which fat deposits in the liver, affects more than 1 billion people globally and is projected to become the leading cause of liver-related mortality within 20 years. Siemens Healthineers will sponsor a session titled "Managing Patient Pathways and Improving Outcomes in NAFLD and NASH" on Tuesday, August 6. According to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, 30% to 40% of adults in the country have NAFLD. Most people with NAFLD have simple fatty liver; experts estimate that about 20% of people with NAFLD have nonalcoholic steatohepatitis (NASH), the most severe form of the disease.
Caspase-generated fragments are being investigated as markers for diagnosing and assessing liver disease. Cytokeratin-18 (CK-18) is the most extensively evaluated analyte for NASH diagnosis. RayBiotech, ARUP, MilliporeSigma, and Thermo Fisher are among the vendors with CK-18 antibody products.
Artificial intelligence (AI) is a nascent area in diagnostics, but there has been news about and several announced partnerships for early AI-driven products, such as RenalytixAI's KidneyIntelX for diagnosing type 2 diabetes and fast-progressing kidney disease, and Paige's platform for analyzing pathology slides for cancer. The AACC's scientific sessions will feature a number of sessions on AI.
In this area, we'll be looking for indications of system usage and also for new product launches. Bruker, Thermo, Waters, and BioMérieux are among the many vendors with mass spectrometry offerings. Thermo Fisher has launched its Cascadion SM clinical analyzer -- a fully automated, random access liquid chromatography-tandem mass spectrometry (LC-MS/MS) analyzer. According to the company, up to 60 samples can be loaded, with additional samples loaded as they are received. Sample racks accommodate samples in different-sized barcoded sample tubes or in sample cups to allow testing of serum, plasma, and whole blood. After initial sample processing, results are produced every two minutes, the company said.
Ebola is in the news again. More than 2,000 people have been infected with the Ebola virus during the ongoing outbreak in the Democratic Republic of the Congo (DRC), according to the World Health Organization (WHO). The WHO and the U.S. Centers for Disease Control and Prevention have also reported the first confirmed cases of Ebola in neighboring Uganda since 2013. Chembio, Cepheid, Biocartis, Roche, BioInnovation, Biohit Oyj, Bioneer, Genalyte, and OraSure are among the many companies with Ebola tests marketed, in development, or allowed for use under an emergency authorization.
Faster IVD test workflows
We expect a lot of discussion on this topic, not only in sessions but also on the expo floor. Siemens Healthineers is showcasing its own customers in its August 6 exhibit hall presentation to better convey the value of testing and the real economics in the laboratory: "Real World, Real Challenges, Real Solutions: Creating New Models in IVD Testing." The 45-minute presentation, moderated by Michael Reitermann, member of the managing board and head of diagnostics at Siemens Healthineers, will feature three clinicians from healthcare facilities and laboratories across the U.S. The clinicians will provide an inside look into how they developed their IVD testing workflows to address their challenges in the clinical lab and at the point of care, leveraging products from the Siemens Healthineers portfolio.
Infectious disease testing automation
What new automation systems and features on systems are available? Abbott will showcase its m2000 RealTime system, which offers a broad menu of IVD assays. The system allows consolidation of PCR testing on a single, reliable, high-performance platform. It integrates advanced automation with one of the largest infectious disease menus available on a single platform, according to the company. Tests include cytomegalovirus (CMV), Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG), hepatitis B virus (HBV), hepatitis C virus (HCV), HIV-1, and Zika virus.
Paired tests with less blood sampling
Ortho Clinical Diagnostics plans to demonstrate its Vitros XT MicroSlide, featuring new, FDA-cleared multitest technology that allows labs to run two tests simultaneously on one MicroSlide. The company said that available test pairs include triglycerides and cholesterol, urea and creatinine, and glucose and calcium.
Last but not least, we will be spending time with our colleagues at LabPulse.com, a new website for clinical lab professionals. LabPulse is making its debut at the 2019 AACC meeting, and you can find them at booth No. 4326, where staff will be available to talk to members of the lab community and sign you up for a free source of daily news and features.
Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group.
Disclosure: LabPulse.com is a sister company of Kalorama Information.