DECN XPRIZE Testing Data for Rapid COVID-19 Testing Technology Yields Near Textbook Results
Data using XPRIZE supplied contrived fluid samples provides results comparable to those seen in the FDA lab testing of donor saliva, as DECN competes for the $5 million prize and GLOBAL validation
LOS ANGELES, CA / ACCESSWIRE / November 23, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters along with its subsidiary Pharma Tech Solutions, Inc., the inventor/manufacturer of the GenViro! Covid-19 Swift Kit truly rapid testing methodology, today announced the results of the completion of its testing for the world-renown XPRIZE, www.xprize.org. The results from the GenViro! testing, using simulated Covid samples and protocols provided by XPRIZE, provided results in 4-9 seconds that were consistent with what the company reports seeing in the FDA lab human donor testing it is concluding at its certified lab and from human donor tests run in the laboratory of its Korean partner.
XPRIZE is the world's leader in designing and operating incentive competitions to solve humanity's grand challenges, in collaboration with OpenCovidScreen, a non-profit founded by scientists and business leaders to drive needed innovation through "Open Science." OpenCovidScreen, was founded along with a coalition of partners calling for the global community to develop accurate, frequent, fast-turnaround, affordable, and easy-to-use screening tests to detect Covid-19 occurrences before they become outbreaks. The $5 million XPRIZE Rapid Covid Testing competition is designed to accelerate the development of high-quality Covid-19 testing that is low cost, reliable, easy to use, and has a fast fast-turnaround, thereby enabling frequent testing.
"While we were guarded about working in the limited time frame provided for the testing on previously unknown and "contrived" samples, we nevertheless anticipated doing especially well on the testing given our faith and belief in our product. I am more than pleased, pleasantly surprised I would add, with the resulting data," said CEO Keith Berman. "We remain more than emboldened about the overall efficacy of the GenViro! Swift Kits. The results provided an identification dichotomy, perhaps for the first time giving rise to a testing category nomenclature for our noteworthy GenViro! Swift product."
DECN's subsidiary Pharma Tech Solutions, conducted its XPRIZE testing at the laboratory of its Korean partner, using the 88 samples provided by the XPRIZE committee. The week-long testing period included two days needed to thaw out the samples, which were received frozen in dry ice. Samples were triple tested in a blind study under the protocols set by the committee. The results have been submitted to the XPRIZE committee for consideration as a finalist, and their announcement is tentatively planned for release on or around December 8th.
The XPRIZE Rapid Covid Testing competition calls on the world's brightest, most innovative minds to develop new, low-cost testing solutions that range from testing devices with 15-minute results to distributed lab testing methods with "next morning" results. Frequent, fast-turnaround, easy-to-use testing enables effective data-driven tracing and isolatingstrategies. Many currently available Covid-19 tests remain expensive, slow, invasive, and are supply-chain limited. XPRIZE Rapid Covid Testing aims to meet the need to scale testing capabilities by approximately 100-times above our current standards, the level needed to more safely return to everyday activities, especially in times of increased community spread.
To amplify its impact, a $50 million "COVID Apollo Project" led by experienced life sciences investors and company builders - including RA Capital, Bain Capital, Perceptive Advisors, Redmile Group, and Samsara Biocapital - will work with OpenCovidScreen, the XPRIZE community, and others to accelerate the best ideas, technologies, and innovations to market and scale them.
Teams can compete in one of the following four categories: At Home, Point-of-Care, Distributed Lab, or High-Throughput Lab. To ensure supply chain diverse solutions, entries are encouraged in a variety of underlying testing approaches (PCR, Isothermal/LAMP/RPA, CRISPR, Antigen-detection, Next Generation Sequencing, and other technologies). Entries will be judged on overall innovation of solution, appropriate performance, turnaround time, scaling properties and frequency enabled, ease-of-use and cost of solution.
Seven major national and regional health plans are collaborating as founding partners of XPRIZE Rapid Covid Testing: Blue Shield of California, Cambia Health Solutions, Inc, Health Care Service Corporation, GuideWell Mutual Holding Corporation, Horizon Healthcare Services, Inc. (NJ), BlueCross BlueShield of South Carolina. The Anthem Foundation and Anthem, Inc., serve as the Founding Anchor Partners. Supporting partners include leading healthcare, laboratory and technology companies: Google, Amazon, Ilumina, Ancestry, Thermo Fisher Scientific, Exact Sciences, Centerview Partners, Twist Bioscience, Opentrons, HudsonAlpha Institute for Biotechnology, and Testing For America.
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN's products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With newly inspired technology, and diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market.
The company's new GenViro!™ products designed to test for Covid-19 are not yet available in the United States and hopefully should soon be available in Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA with additional submissions to take place in the near future. The company has also signed an agreement with an FDA and CLIA certified US, Pennsylvania-based testing partner to complete testing per current FDA guidelines and continues to look forward to the FDA authorization of its EUAs.
Beyond all of our testing activities, the company has received word from several of its large GenUltimate! blood glucose product distributors who are seeking to have GenViro! added to their Amazon product offerings upon FDA approval. Currently, Amazon only offers special licenses for point of care and professional use medical products, which would preclude the individual use GenViro! Kit from being available on Amazon, even after FDA approval is secured. Two of the company's GenUltimate! product distributors have these "professional use" arrangements with Amazon, with a third distributor application in the works, although the company may determine that it is in its best interest to offer limited exclusivity to one distributor once FDA authorization is achieved.