DECN Says its Newest GenViro! COVID-19 Swift Kit Saliva Testing Option Can Play an Extensive Role in the Re-Opening of Schools as Company Awaits FDA Authorization
"Designed to be swift, safe, non-invasive, and accurate, GenViro! Saliva Based Swift Kit planned to help send students of all ages back to school"
LOS ANGELES, CA / ACCESSWIRE / July 17, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today stated that the country does have the know-how and means to provide, "swift, safe, non-invasive and accurate testing methodology to help send our kids back to school." DECN has been a provider of diabetic testing products for almost two decades. Diabetic glucose test strips are a safe and effective technology used by millions of diabetics around the globe for years. The company's patent pending impedance based technology is used on all of its Covid-19 Swift Kit test kits. DECN's Pharma Tech Solutions subsidiary currently has two applications for FDA EUA authorization of its GenViro! blood testing kits to detect the Covid-19 virus. More recently, DECN announced it is testing and will be filing another EUA for its non-invasive saliva testing kits using the same technology consisting of testing strips and slightly modified meter software as its Covid-19 blood test kits. Both forms of test kits could help all schools, from elementary to the university level, open more safely, as well as offer testing at the point of care for the students and the adults working in these institutions. Recent tests completed on both the whole blood and saliva methodologies show an almost identical testing profile (see below).
The company has been conducting its testing efforts overseas while actively seeking FDA approval for testing protocols in the U.S. DECN's Pharma Tech Solutions subsidiary first submitted its proposed GenViro! professional use device to the FDA on April 3, 2020. The request for a saliva based method came to the company directly from its international distributor. Now DECN believes that there are many other uses for the saliva based kit, "back to school" being a current most important use.
The company plans to provide the new single use saliva testing kit option to its professional and individual use finger stick GenViro! Covid 19 Swift Kit test kits designed to identify Covid-19 viral load. Test reporting for the GenViro! finger stick kits are currently producing results at :10.5 seconds, and initial testing completed on the saliva version of the kit should yield even faster results since the saliva testing will not require any sample correction. The GenViro! Covid-19 Saliva Swift Kit is completely non-invasive.
According to a July 16, 2020 article in The Wall Street Journal entitled Colleges Plan Robust Testing of Students, Faculty for Fall: "Universities, seeking to bring students back to campus this fall are laying out reopening plans that rely heavily on their health departments arranging widespread frequent testing of students, faculty and staff…Testing is widely acknowledged as necessary to track the spread of the virus and to suppress clusters once they emerge. But, the nation's ability to conduct and process Covid-19 tests is already straining to complete 600,000 a day … Adding tests for hundreds of thousands of students to the mix, as some say, could cause further backlogs and equipment shortages."
"The country as a whole agrees our children must get back to school and we all want that to happen as safely as possible … for the kids, the teachers, administrators and school workers, and especially the parents. Robust testing at all schools no matter the education level will be critical. Once we have the exact US testing protocols agreed to with the FDA, and we hope they act fast, we will be in a position to immediately test. Based on what we have already experienced in overseas testing, we are confident our testing will produce the desired results at which point we can very quickly move to manufacture and make these tests available to schools across the US," said DECN CEO Keith Berman.
Preliminary testing using saliva from human donors indicated that the saliva exhibits a comparable, and in fact favorable, impedance curve profile when compared to whole blood. In addition, saliva does not contain hematocrit (an abundance of or non-abundance of red blood cells) which on our whole blood based product required adapting our patent pending TBG technology to the GenViro! test strip.
ABOUT DECISION DIAGNOSTICS CORP:
Decision Diagnostics Corp. has been the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters for 18 years. 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. The company's GenViro!™ products are designed to test for Covid-19, and applications for Emergency (EUA) Waivers have been submitted to the U.S. FDA. The finger stick test kit is currently being readied for international sales and an agreement for distribution has been signed for sales to commence in multiple countries including India, Malaysia, Singapore, Nepal, Bangladesh, Sri Lanka, Indonesia, Thailand, Vietnam and Australia. Registration in those countries where such documentation is required is the responsibility of the distributor.
Forward-Looking Statements:
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of July 16, 2020, regarding the company's business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
CONTACT INFORMATION:
Decision Diagnostics Corp.
Keith Berman
(805) 446-2973
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
SOURCE: Decision Diagnostics Corp.
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