With Favorable Testing Results Anticipated on November 13 From Our FDA and CLIA Certified Laboratory, DECN Estimates Completion and Filing of 3rd FDA EUA Application in the Next 3 Weeks
LOS ANGELES, CA / ACCESSWIRE / November 12, 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 announced its donor study has entered its final stages, and that having yielded better and quicker than anticipated results a separate feasibility study will not be required. The company is now actively testing known positive and negative Covid-19 patients in an effort to finish its FDA EUA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed. We are reviewing drafts of this application currently. The donor study will provide exact data requirements for FDA EUA, EU CE Mark and Russian Federation applications for the GenViro! Saliva Swift Kit for the detection of Covid-19.
'Testing for GenViro! has been so encouraging that on Tuesday, November 10, 2020 our certified testing lab partner informed us that we can avoid doing two studies and instead move to direct patient testing of positive and negative Covid-19 human samples required for FDA submission. That's taking place right now' said CEO Keith Berman. 'As such, we have been informed that testing is in the 'home stretch,' and we estimate an FDA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed.'
Berman continued 'The testing of positive and negative human saliva samples is demonstrating a number of critical findings. One such finding concerns the identification of sample results where we anticipate positive results to be just that, positive, and the identification of negative results to also be just that, negative. In marked contrast to the expected GenViro! Swift Kit result reporting, there are popular testing methods currently on the market that have what we consider largely unacceptable false-negative rates. Numerous news articles have confirmed this. We have also commented on this. The FDA is paying particular attention to the incidence of false-negative reporting.'
Berman further stated, 'The current testing will also allow us to do the final programming of algorithms for the GenViro! Swift Kit meters, fixing the version level at version 1.7. We will also be enhancing our meters with the ability to provide a qualitative measure of certain probabilities. This additional meter feature, version 2.1, is expected to be implemented early in 2021. We will expand on that capability in subsequent announcements as more results become available and are validated. With all of this data available in approximately 10 seconds, at the actual point of care or testing, we believe now more than ever that we have what will turn out to be the most desirable technology available for rapid and reliable Covid detection.'
DECN had previously targeted the fourth quarter, 2020 for FDA EUA, EU CE Mark and Russian Federation submissions. We do not anticipate any deviation from this schedule, at least as far as the application from the Russian Federation is concerned. As was highlighted in a prior announcement, the company is emboldened about the efficacy of its saliva technology because of recent media and academic reports showing that saliva may well be the best way to detect the presence of Covid-19 in a virtually non-invasive method.
GenViro! Swift Kits are not yet for sale in the USA, Puerto Rico or associated territories. FDA EUA applications are on file and another application is pending.
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 or 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.
The same data that will be produced by the company's Pennsylvania testing partner will be used for submissions to the EU and Russian Federation. We will also use data provided by our Korean R&D and contract manufacturing partner as part of their extensive product development schedule and as part of the XPRIZE initiative which is progressing as yet a third validation of the testing methodology.
Beyond the testing, the company has received word from several of its large GenUltimate 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. The company continues to recruit and accept applications from prospective domestic and international distributors. Inquiries can be directed to firstname.lastname@example.org.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of November 10, 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.
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SOURCE: Decision Diagnostics Corp.
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