Big Developments at AACC 2018 – New Alzheimer’s Test, Chagas Detection, Faster Microbiology and New Molecular POC and B12 Testing Improvements

ROCKVILLE, Md.July 30, 2018 /PRNewswire/ — Kalorama Information noted the following interesting new products and other developments at the upcoming Clinical Expo and in the current sessions of the American Association for Clinical Chemistry 2018, which is underway in Chicago, IL. Kalorama Information is a leading market analysis firm covering the in vitro diagnostics. The company will publish its Worldwide Market for In Vitro Diagnostic Tests, 11th Edition on August 27th.

Breakthrough Alzheimer’s Disease Assay: Currently, the diagnosis of Alzheimer’s is largely based on clinical symptoms, including cognitive testing, with a significant number of patients diagnosed when their disease has already advanced. The IVD Industry has sought to change that. Now, Roche Diagnostics has announced that U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia. A diagnosis of AD based on cognitive measures alone is only correct in 70 – 80 percent of cases. The firm says measuring biomarkers with CSF immunoassays, associated with AD pathology, increases certainty of a diagnosis of AD and can help to evaluate the progression of the disease.

Chagas Test: Chagas is spread by insects nicknamed “kissing bugs,” but symptoms are anything but benign. An estimated 8 million people are infected worldwide, mostly in Latin America. Chagas disease is clinically curable if treatment is initiated at an early stage. Thus the demand for diagnostics. If undetected, patients may be symptom-free but some may progress to clinical forms of the disease (cardiac, digestive and/or neurological), which can be life threatening if left undiagnosed and untreated. Ortho Clinical Diagnostics will demonstrate the effectiveness of its  Anti-T. cruzi (Chagas) Assay at the meeting.  A poster session will feature a method Comparison of the company’s VITROS® Immunodiagnostic Products Anti-T. cruzi (Chagas) Assay* to the Ortho® T. cruzi ELISA Test System. The former test is one of several available on the company’s recently CE-Marked System VITROS® system using dry-slide technology.

holoTC-based Anemia Test: B12 is an important factor for establishing patient health, but according to Siemens Healthineers, the way it is detected is changing. Several studies support that holoTC is a better indicator of vitamin B12 status than total serum cobalamin for anemia detection. holoTC is the only form of vitamin B12 that is taken up and used by cells of the body. Siemens Healthineers is displaying the ADVIA Centaur Active-B12 assay measures holoTC, the company says is the only form of vitamin B12 that is taken up and used by cells of the body.

SHERLOCK Gene Editing Update: AACC will once again be a central point for gene editing and its potential use in diagnostics. Professor Jim Collins is set to deliver a much-awaited plenary speech on the fusion between synthetic biology and CRISPR technology. SHERLOCK is a gene editing system that differs from CRISPR in that it is centered around the activity of Cas13a/C2c2.  The team working on SHERLOCK at the Broad Institute and MIT originally developed the diagnostic tool to not only identify, but also quantify genetic signatures from Zika and Dengue viruses, on a simple and inexpensive paper strip. Recent developments in the technology, to be discussed in Collins’ talk at AACC, have allowed them to refine the technique further to enable identification of multiple molecular targets, as well as amplification of the detection signal for increased sensitivity.

Self-Test Coagulation: Improving coag testing has long been a goal of IVD vendors.  Roche Diagnostics highlighted its CoagCheck Vantus system. The system, which is designed for Warfarin patients to monitor their coagulation levels, includes built in Bluetooth technology. Patients can now see their results on the app and have the results sent to their healthcare provider wirelessly. Patients can test at home, or wherever it’s convenient and the system offers an alternative to drawing blood from a vein.

Error-Free HbA1c Testing: HbA1c is one of the fastest-growing test areas in terms of revenues, pegged by Kalorama for over 10% revenue growth in recent studies. That it is a focus area of innovation is not surprising. Abbott Diagnostics will be displaying the Afinion™ 2 analyzer, which the firm says makes it fast and easy to test quantitative determinations of HbA1c, Lipid Panel, ACR, and CRP. The platform is designed to enable simple and fast on-the-spot testing in physician offices, clinics, community health centers, and hospital outpatient clinics. Each test cartridge has been precision engineered, containing an integrated sample collection device and all necessary reagents for a single test. Erroneous results are eliminated with integrated error detection and self-check systems.

Speeding Up Microbiology: A recent trend has been the idea of vendors transforming specialty analyzers with functions seen in more routine bulk testing so that lab productivity can improve.  bioMérieux will be displaying its BACT/ALERT VIRTUO blood culture detection system. The flexible platform fits into nearly any size lab, even outside the routine microbiology lab. The motion activated loading system requires the operator to have minimal skill level to load the instrument. After bottles are loaded – “smart scanning” images the bottle to provide instant recognition of barcode labels and automated blood volume level detection. Bottles are loaded and unloaded into newly designed racks by a robotic arm. High fidelity optics and new algorithms are incorporated to increase performance and time to detection.

New Molecular POC Platform: Lexington, MA-based Sekisui Diagnostics is offering Silaris™, a platform is cleared for the detection of the influenza A and B virus, showing a sensitivity of 97% for Flu A and 94% for Flu B. The system utilizes proprietary OscAR™ technology within a state-of-the-art microfluidic cassette allowing facilities to implement an affordable, high performing, CLIA Waived, molecular testing option to diagnose and treat patients quickly and effectively.

New Opioid Tests: Roche will introduce the new Hydrocodone (HYD), Buprenorphine (BUP), and 6-Acetylmorphine (6-AM) assays, which expand its existing Drugs of Abuse Testing menu offering. These screening assays are available on the cobas® c 501 & 502 analyzers, allowing for quick response to growing testing demands due to the opioid epidemic. HYD and BUP are designed to detect specifically one parent drug and the main metabolite in human urine while 6-AM detects the unique metabolite of heroin.

POC HCV Test in the Future: According to the World Health Organization, an estimated 71 million people are living with HCV infection, mostly in low- and middle-income countries. The disease claims nearly 400,000 lives each year, predominantly through cirrhosis and hepatocellular carcinoma. Despite being widespread, HCV often manages to go undetected: 80% of people infected are not aware of their status. Chembio announced a collaboration with the Foundation for Innovative New Diagnostics (FIND) to expedite the feasibility testing of a rapid diagnostic test for hepatitis C virus (HCV). Chembio is one of three companies selected by FIND for HCV feasibility studies, and Chembio will use its patented DPP technology platform for the testing of a rapid HCV core antigen assay.

Small to Mid-Sized Lab Solution: Carolina Liquid Chemistries’s EasyRA® is a high-speed benchtop clinical chemistry analyzer that accommodates labs in small locations, physician offices or urgent care centers. With 300 tests per hour (480 with integrated ISE), an intuitive user interface, and the ability to analyze STAT samples in less than 8 minutes, the EasyRA’s all-in-one system now allows laboratories to perform moderately complex urine drug screens and general chemistry tests on a single analyzer.

To-Be-Announced Small-Sized Immunoassay: Shenzhen, China-based Mindray Medical will unveil what it claims is one of the world’s smallest, fully automated chemiluminescence immunoassay analyzers, and other industry-leading laboratory solutions.

Handheld Hemoglobin: EKF Diagnostics will be presenting  and DiaSpect Tm The DiaSpect Tm Hemoglobin Analyzer provides immediate hemoglobin results from a hand-held analyzer. Results are in less than two seconds and the system features reagent-free cuvettes, that are unaffected by humidity and temperature, as well as an internal battery provides 40 days or 10,000 tests continuous use.

New Middleware Data Solution: Siemens Healthineers will preview the soon-to-be-released Atellica® Data Manager1 that delivers clinical details lab managers need to make informed decisions. Atellica Data Manager is built on the powerful CentraLink® solution currently in use by 1,500+ laboratories in more than 50 countries to help optimize clinical operations, increase testing volumes and improve turnaround times.

Palm-Sized Flu Detector: Mesa Biotech Inc., a privately-held, molecular diagnostic company has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis. The system provides a palm-sized, reusable dock with disposable test cassettes, the Accula System, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing.

AACC Honors CML Treatment Pioneer: The American Association of Clinical Chemistry recognized its academy winners during the opening plenary session of the 70th AACC Annual Scientific Meeting & Clinical Lab Expo at McCormick Place Chicago on Sunday, July 29. The Wallace H. Coulter Lectureship Award was awarded to OHSU Knight Cancer Institute Director Brian J. Druker, M.D for his pioneering role in shaping the fields of precision medicine and targeted cancer drugs. Dr. Druker is the Director of the Knight Cancer Institute at Oregon Health & Science University, Dr. Druker’s research was instrumental in the development and approval of imatinib, which has transformed the management of chronic myeloid leukemia (CML). Imatinib, a tyrosine-kinase inhibitor, received the fastest approval in U.S. Food and Drug Administration history and turned a previously fatal disease into a manageable condition. Approximately 90% of patients with CML who are treated with imatinib are still alive 5 years after starting treatment. Dr. Druker’s work on imatinib introduced the concept of targeted therapy and laid the foundation for a new direction in oncology—precision medicine—which is focused on a personalized approach to cancer treatment.

Cardiac Marker Innovator Honored: At the Sunday, July 29th awards ceremony, the AACC awarded its Outstanding Lifetime Achievement Award in Clinical Chemistry and Laboratory Medicine to Dr. Fred Apple, who is the medical director of the Clinical Laboratories, Clinical Chemistry, Clinical and Forensic Toxicology and Point of Care Testing. Dr. Apple’s research has centered in the areas of cardiac biomarkers in acute coronary syndrome and heart failure; fetal protein expression in injured skeletal muscle, specifically addressing the biochemistry of exercise; and postmortem redistribution of drugs. Dr. Apple is known for discovering that the reigning biomarker for heart attacks, creatine kinase-MB (CK-MB), was elevated after intense exercise—an observation that helped transform the field of cardiac biomarkers. This was something he, as a runner, discovered from testing his own blood. (Other award winners that were honored on Sunday are at;-celebrates-achievements-in-laboratory-medicine.)

Fast Chikungunya Assay: J. Mitra is offering Advantage Chikungunya IgM Card. The card is a visual, rapid, sensitive, qualitative immunoassay for the detection of Chikungunya specific IgM antibodies in human serum or plasma. The system is a one step test procedure based on Sandwich Immunoassay principle, which offers results in 15 minutes.

New PCR Master Mix: Biofortuna announced that it launched ampDRY™, its patent pending stabilized master mix for PCR applications. ampDRY hotstart master mix has been developed to enable complete end-stage or real-time PCR assays to be stabilized in a dry format at ambient temperatures for at least 12 months, negating the requirement for cold chain shipping and storage. ampDRY allows the straightforward creation of stabilized assays: oligonucleotides are combined with the ampDRY reagent and dispensed into PCR vessels, then stabilized by controlled air drying.