DECN Provides Update on Accomplishments and Pathway to Securing FDA EUA Approval for its COVID-19 "Transmission Indicating Testing" Methodology
LOS ANGELES, CA / ACCESSWIRE / August 26, 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 through its subsidiary Pharma Tech Solutions, Inc., today provided the following "Update" on its effort to produce a Covid-19 Swift Kit antigen testing methodologies and secure FDA EUA approval for its products. The company has been working diligently with its Korea-based testing and product development partner to perfect both saliva and blood Covid-19 rapid testing Swift Kits, whose foundation is based on a modified test strip and meter reader technology that the company has been manufacturing and distributing with its diabetes monitoring products.
"As the experts have pointed out, the country needs to change its testing platform in order to identify people when they are most infectious, and while at the same time potentially being asymptomatic, and that's what our Genviro! Saliva testing products are designed to do," says DECN CEO Keith Berman. "Important advancements have been made toward selecting a lab, or perhaps two labs, to do our US-based testing on our saliva methodology that we believe should be more readily accepted by the FDA, and eventually by individuals for at-home use as it is completely non-invasive. We have engaged a special consultant to expedite this process, and as a result he recently introduced us to a third laboratory located on the east coast. Our decision is now between two laboratories associated with major university hospitals and a third reference laboratory currently involved in its own (non-competitive) EUA in process. All three laboratories deal with saliva based methods. The two laboratories associated with university hospitals already have approved EUAs through the FDA. However, none of these laboratories offer methodologies that provide results as expeditiously as our GenViro! Swift Kit that has recorded lab test results in (10.5 seconds), and, even more significantly, offer true point of care testing. As discussed previously, the GenViro! Swift Kit will be tested in two phases; the first phase providing results to assist the company in seeking approval in the EU, Russian Federation and the ten other nations where we have signed distributor agreements. The second phase testing will be for the FDA EUA authorization.
Beyond selecting its testing partner(s), the Company is now discussing opportunities for pilot program participation with Los Angeles Mayor Eric Garcetti's office, which has been among the most aggressive in pushing for faster and simplified at-home testing methods as the virus has hit California with particular fury. That potential relationship would have us working directly with the University of Southern California, which is overseeing most of LA's pilot programs.
The company is now also finalizing the software updates and algorithms for its GenViro! Swift Kit testing meters that will test (read) the saliva provided by a human donor. No changes were required to the GenViro! test strip which has the capability to work with whole blood, blood plasma and saliva. Upon completion of US-based testing with the about-to be-selected lab partner, the finished GenViro! Instructional Package Insert (IPI) and soon to be completed video will be submitted in conjunction with the new FDA application. The company expects all this to occur prior to the end of September.
"We will also seek to share some testing data as it becomes available from our Korean partners. Right now we are reviewing exceptional accuracy in our testing as well as reproducibility, with impedance values across the entire spectrum of human donors showing less than a 5% variance. Our Korean partners' tests of known negative patients has exceeded what the FDA guidance states. While this is the first such data to come in, GenViro! is operating at a level well above what is currently required by the FDA and beyond what experts such as Harvard's Dr. Michael Mina are saying should be necessary for simple, rapid testing that he says, ‘provides the transmission indicator testing needed'. We expect additional data to arrive shortly," said Berman.
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 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!™ product designed to test for Covid-19, is not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of August 25, 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.
SOURCE: Decision Diagnostics Corp.
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