• by Bruce Carlson
  • January 18 2017
  • IVD

Top 5 News Stories in In Vitro Diagnostics - January 2017

Top 5 News Stories in In Vitro Diagnostics - January 2017

     In vitro diagnostics companies are starting the new year by announcing  partnerships to advance cancer genetics, both by making sequencing data easier to interpret and by pushing the boundaries of liquid biopsy. Meanwhile, scientists have developed a 20-cent centrifuge for developing countries, doctors are contending with potential false positives in a Zika test, and CMS has begun collecting market data to set new laboratory reimbursement rates for 2018.   Here are the top in vitro diagnostics stories of January 2017.   Kalorama covers the in vitro diagnostics (IVD) market and all of its test segments in its report, The Worldwide Market for In Vitro Diagnostics, 10th Edition.  

Computers Bring Cancer Genomics Closer to the Clinic

     Illumina, Inc. announced this month that it will partner with IBM Watson Health in an effort to standardize and simplify interpretation of cancer gene variants.  The added computing power will help scientists interpret results more quickly, according to a press release, reducing a week’s worth of digging through medical literature, clinical trials compendia and professional guidelines to minutes. Watson for Genomics software will be available bundled with Illumina’s TruSight Tumor 170 solid tumor profiling panel in early 2017. Though it is intended for research use, diagnostic laboratories can take the process through validation for CLIA certification and use the technology clinically.  Meanwhile, Illumina also announced a collaboration with Royal Philips to incorporate Illumina’s sequencing into Philips’ IntelliSpace Genomics clinical informatics platform for cancer, which also incorporates data from radiology, immunohistochemistry, digital pathology, medical records and lab tests into an integrated dashboard.
     Though this partnership also is intended for research only, the press release notes that the collaboration will move precision cancer diagnosis out of the realm of academic centers and “unlock the value of genomics for a much wider group of laboratories and care providers.”

Coming Soon, Largest Liquid Biopsy Panel Ever

     Guardant Health announced this month that it is partnering with several major pharmaceutical companies, including AstraZeneca, Merck and Pfizer, to develop a 500-plus-gene liquid biopsy panel.  This will be the industry's largest commercially available liquid biopsy panel, according to a press release, and will speed cancer trials and drug development. A single blood draw would quickly screen a cancer patient for virtually every targeted therapy clinical trial available, Guardant says.   The company currently offers Guardant360, an in-house liquid biopsy that tests for 73 cancer genes in advanced solid tumors. The expanded panel will be available in mid-2017. Guardant Health also plans to release a CLIA-certified version for its pharmaceutical partners, the press release says.   The Guardant360 uses a “digital interference engine” in its Digital Sequencing platform to detect tumor DNA circulating in blood with few errors or false positives.
     “We are now confidently detecting a single molecule of mutant circulating tumor DNA in a 10mL tube of blood drawn from an advanced cancer patient," said Helmy Eltoukhy, Guardant Health CEO and co-founder in a statement.
     A discussion of recent developments in circulating tumor DNA, as well as circulating tumor cells (CTCs) and tissue biopsies is available in a recent Kalorama Information blog post called, “CTCs, cfDNA and Tissue Biopsies: A  Comparison”. Also, these technologies and the markets for them are fully explored in Kalorama Information's report, Cell-free DNA Markets.

DIY Paper Centrifuge Enables Low-tech Point-of-care Diagnostics

     Researchers at Stanford University reported this month in Nature Biomedical Engineering that they had made a cheap, human-powered paper centrifuge that could be used in resource-poor areas as the starting point for in vitro diagnostics.  The ‘paperfuge,’ as they call it, was inspired by a whirligig toy dating from 3,300 BC. It costs about 20 cents, requires no electricity and can separate pure plasma from whole blood in less than 1.5 minutes.   Their goal was to find an alternative to the traditional centrifuge, which is large, expensive and requires electricity. With the paperfuge and blood from a fingerstick, they were able to obtain red blood cells for hematocrit, as well as pure plasma that could be used for rapid diagnostic tests. With 15 minutes of spinning, they achieved adequate separation to test for malaria and other parasites.
     The scientists experimented with materials beyond paper, and even made a version of the hand-operated centrifuge out of a silicon-based polymer for microfluidics that might one day integrate with lab-on-a-chip devices.
     “The in-depth analysis of a simple toy has provided broad inspiration for developing human-powered, instrument-free POC devices,” they write. “The variety of materials (paper, polymers) and rich design landscape offer potential for electricity-free integrated POC devices.”

Caution Urged as Some Zika Tests Yield False Positives

     The FDA issued a safety alert in late December about a serological test for Zika virus, after Laboratory Corporation of America (LabCorp) noticed the test was delivering more false positives than expected.  The FDA said it’s not clear if the problem is with the testing facility or with the test itself, the ZIKV Detect IgM Capture ELISA by InBios International, Inc., but urged doctors to consider any positive serological result preliminary and to wait for confirmatory testing before making any clinical decisions.  

     While the FDA has yet to approve a test for Zika virus, it granted Emergency Use Authorization in 2016 for several tests, including ZIKV Detect IgM Capture ELISA. LabCorp noticed the false positives after migrating from the CDC’s Zika MAC-ELISA test to ZIKV Detect.  Both tests performed well in the past, according to the FDA’s statement, but “the CDC confirmed less than half of those presumptive positive results captured by LabCorp through the ZIKV Detect test.”

First Payment Records Due to CMS This Month

     The Centers for Medicare and Medicaid Services (CMS) begins collecting market data this month from many clinical laboratories under the final rule of the 2014 Protecting Access to Medicare Act (PAMA).  Laboratories that meet certain criteria have three months to report their payment rates and corresponding volumes for tests ordered by private payers in the first six months of 2016. CMS will use the data to calculate weighted median payment rates to be paid by Medicare starting in 2018.  The new pricing could drastically cut Medicare reimbursement for routine, high-volume tests, according to the Kalorama Information blog post, “With Final Rule, PAMA Set to Spark Changes in Lab Market and IVD Strategy”.
     Because rates for these tests will be based on data from large clinical labs with high economies of scale, Medicare may reimburse small labs below cost, making these tests unfeasible to perform at decentralized locations.
     A full discussion of the PAMA rule and its implications is available at the Kalorama Information blog. For more information regarding the impacts of PAMA and the Affordable Care Act on the U.S. IVD market, Kalorama Information offers United States Market for In Vitro Diagnostic Tests.