What We’ll Be Looking Out for at #AACC2019

Kalorama Information will be at the 2019 American Association for Clinical Chemistry Annual Meeting and Clinical Lab Expo in Anaheim, CA with our analysts, gathering market insights and reporting from the meeting.  These are among the many developments we’ll be looking out for.

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, according to Kalorama Information’s Molecular Point-of-Care Market report.  But how far have systems progressed?   How are sales?  Where are we with new CLIA-waived tests?  Abbott, Cepheid, BioFire (bioMerieux) and Roche lead in this segment, but Quidel, Meridian, Mesa Biotech, and Biocartis are among those with offerings as well.

Sepsis – Given the laboratories role in catching this critical disease, it will not be surprising to see sepsis a focus at AACC Anaheim.     What we are most interested in: New PCT test products, support/findings on the use of PCT as a biomarker and progress on new sepsis biomarkers our analysts will look out for.  There will be several sessions and exhibit hall demonstrations related to this topic.  A Tuesday August 6th Exhibit Hall theater presentation supported by Thermo Fisher Scientific will deal with PCT as a tool in Antibiotic Stewardship in Hospitals. bioMerieux, Diazyme, iCubate, Nova Biomedical, Response Biomedical, VITRO, Joinstar Biomedical Technology Co. are among the companies with sepsis products at the meeting.

It will be interesting to see commentary from laboratorians, speakers, or vendors on 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/79921),

High Sensitivity Cardiac Troponin Markers – We’ll be on the lookout for discussions, for new menu adds and new analyzers and tests.  This is one of the fastest growing markers according to Kalorama’s latest report on the market https://kaloramainformation.com/product/the-world-market-for-biomarkers/  Of note is Roche’s workshop:  From the Lab to the Emergency Department: The Benefit of hsTnT in the US Since 2017.  Nam Tran, PhD, Directory of Chemistry & Toxicology, Department of Pathology & Laboratory Medicine at University of California Davis will share how hsTnT improved chest pain assessment, emergency department efficiency, CMS quality measures and resource utilization at the University of California, Davis , Other vendors with marker-related products include: INTEKBIO, NVIGEN, Polymedco, Inc., Precision Biosensor Inc. Response Biomedical, Seasun Biomaterials and Seegene.  

RNA Sequencing – Attention to RNA and its potential for diagnostics is on the rise. 129 AACC Clinical Expo Vendors have cited RNA in their listing, including ELITEch, Ximedica, Seegene, Roche, Promega, IDEX, Eurofins, Hologic, BioTechne and BD. We’ll be looking for discussions or product launches related to RNA-based diagnostics for detection of gene fusions and differential expression of known disease-causing transcripts. RNA-seq, method for high throughput sequencing of RNA molecules extracted from cells or tissue, has several clinical applications including detection of disease-relevant aberrant gene expression, gene fusions, and expressed sequence variants.
A recent AACC webinar covered recent developments in the space. https://www.aacc.org/clinical-chemistry-trainee-council/trainee-council-in-english/pearls-of-laboratory-medicine/2019/rna-sequencing

Lab Pulse – There is a paucity of news sources covering the laboratory industry.  A highlight of the meeting will be Lab Pulse.com Booth – 4326 where staff will be available to talk to members of the lab community.  Here laboratorians and pathologists can sign up for a new source of daily news from a laboratory point of view.  IVD vendors can see potential sponsorship opportunities and ways to reach clinical system users.  Lab Pulse is a partner publisher of Kalorama Information.

Antibiotic Resistance (AMR) detection – We expect many offerings in this area and for IVD’s role in testing to be a continued discussion topic on the exhibit floor.   Abbott’s ID Now can provide results in 13 minutes or less, with positive results available in about five minutes. Abbott says such a rapid result enables clinicians to make more confident and informed treatment decisions during a single patient visit.  bioMerieux continues to participate in the AMR Challenge, a Centers for Disease Control and Prevention (CDC) initiative to bring government, healthcare and industry leaders together in a year-long concentrated effort to accelerate the fight against the public health threat of antimicrobial resistance (AMR).    Streck’s new line of CE-marked antibiotic resistance monitoring and detection (ARM-D) kits are now available for European Markets.  The Streck ARM-DKits, ampC and Beta-Lactamase are multiplex real-time PCR reagents for the detection of more than 450 ? lactamase gene targets

Diabetes – Given the unfortunate incident rates and the severity of the disease, this is an important area for test innovation. 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 will take place in Anaheim, CA at the Hilton Anaheim. The group sets test certification standards.

Vendor activity is expected to be robust.  EKF Diagnostics, will display 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 will be offering 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 will promote 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 will sponsor 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 are among vendors with CK-18 antibody products.

AI:   AI is a nascent area in diagnostics, but there have been a number of announced partnerships and early products.    In recent news, a machine-learning method was able to predict biomarker expression in breast cancer through analyses of hematoxylin-eosin (H&E) stained images alone, on par with standard immunohistochemistry, in a single-center, retrospective study of publicly available cases, Israeli researchers reported on July 26 in JAMA Network Open.  When it came to predicting estrogen-receptor expression (the status of which is needed to guide therapy), the method demonstrated accuracy of 91% to 92%, with results in line with what has been reported for traditional IHC, according to the researchers (JAMA Netw Open, July 2019, Vol. 2:7, e197700.  (per LabPulse.com) – https://www.labpulse.com/index.aspx?sec=sup&sub=lab&pag=dis&ItemID=800235

Mass Spectrometry:  We’ll be looking for indications of system usage and also for new product launches.  Bruker, Thermo, Waters, bioMerieux, are among many vendors with MS offerings.  Thermo Scientific™ has launched a 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, the company says that test results are produced every two minutes.

Ebola Testing.  Ebola is in the news again.  As of More  than 2,000 people have been infected with Ebola virus during the ongoing outbreak in the Democratic Republic of Congo (DRC), according to the World Health Organization (WHO). The WHO and the U.S. Centers for Disease Control and Prevention (CDC) have also reported the first confirmed cases of Ebola in neighboring Uganda since 2013. The first confirmed patient became infected while visiting the DRC, then returned to Uganda and sought treatment. Chembio, Cepheid, Biocartis, Roche, BioInnovation, Biohit OY Bioneer Corp, Genalyte Inc., OraSure are among several companies with Ebola tests either marketed, in development, or allowed under emergency authorization.

Faster IVD Test Workflows:  We expect a lot of discussion on this topic, not only in sessions but on the Expo floor.  Siemens Healthineers is showcasing its own customers in its 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 of SiemensHealthineers AG will feature three clinicians from healthcare facilities and laboratories across the U.S. who will provide an inside look into how they have evolved their IVD testing workflows to address their challenges in the clinical lab and at the point of care, leveraging products from the SiemensHealthineers portfolio. 

Infectious Disease Testing Automation: What new automation systems and features on systems are available? Abbott will showcase its Abbott m2000 RealTime System is a highly flexible and proven solution featuring a broad menu of IVD assays.  The system allows consolidation of PCR testing on a single, reliable, high performance platform   The Abbott m2000 RealTime System integrates advanced automation with precise and proven performance of one of the largest infectious disease menus available on a single platform.  Tests run include  CMV,  CT/NG, HBV, HCV, HCV,  HIV-1  and ZIKA.

Paired Tests with Less Blood Sampling: Ortho Diagnostics plans to demonstrate its VITROS® XT MicroSlides, featuring new, multi-test technology that allows labs to run two tests simultaneously on one MicroSlide, have been cleared for market by the U.S. Food and Drug Administration.  The company says that available test pairs include: triglycerides and cholesterol; urea and creatinine; and glucose and calcium.   The company says pairing can improve  test throughput without requiring additional or larger analyzers.

Other recent announcements of interest: