DECN READIES ITS 2ND EUA AMENDMENT WITH THE FDA FOR ITS GENVIRO! SWIFT PROFESSIONAL COVID-19 :15 TEST KIT, AND ALSO ANNOUNCES ITS FURTHER SUPPORT FOR MORE AND CONTINUED WORLDWIDE COVID-19 TESTING
LOS ANGELES, CA / ACCESSWIRE / June 12, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today announced its continued support for additional COVID-19 testing on a worldwide level, as the company prepares a Second Amendment to its Emergency Use Application (EUA) that was completed and first submitted to the FDA on April 3, 2020.
This Amendment specifically addresses what the company believes are positive changes in the FDA Guidance and/or platforms (EUA updates 4 and 5) initiated on May 4 and May 11, 2020, respectively. The company believes that both of these guidance additions/changes help us as we present our GenViro! Swift :15 Kit and prepare it for commercial sale in anticipation of securing regulatory approval. In addition, the company emphasizes its ongoing support for increased testing as the US is experiencing a substantial uptick in the number of Covid-19 infections in approximately 20 states and the critical need to increase testing worldwide.
Keith Berman CEO of DECN commented, “It is clear from the data and in pronouncements from the vast majority of public-health experts that we need more testing, its accuracy needs to improve, and we need faster results. That’s exactly what we are working on with our Covid -19 :15 Swift Kit and why we are filing this 2nd amendment with the FDA.”
Leading outlets such as The New York Times have said the current state of testing is not sufficient, calling it “The Wild West”. In a late April article the Times also highlighted the fact that “The FDA must stick to its normal process for review but expedite it by giving top priority with its reviewers and bring more on if necessary.” Berman continued, “We agree and also believe that this will certainly support smaller, innovative companies with potential game-changing technologies like ours who remain anxious to demonstrate in the market alternative testing solutions.”
The company had previously announced that separate Emergency Use Applications (EUA) had been filed and have received Pre-EUA Acknowledgement letters from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Swift Kit for professional use in commercial and group settings and device (serial number) PEUA200947, GenViro Covid-19 Screening Kit for at- home use.
Decision Diagnostics through its Pharma Tech Solutions, Inc. subsidiary is an 18-year old diabetes testing products firm, high-level manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for its own proprietary regulated medical devices. Subject to FDA authorization of its GenViro! Swift kits, DECN anticipates adopting its further developed impedance technology, first utilized for its diabetic testing products, to implement the manufacturing and distribution of its GenViro! Covid-19 :15 Swift test kits in the U.S., Canada, and worldwide.
Mr. Berman continued, “While we will continue working with the FDA for an authorized EUA for our GenViro! Covid-19 :15 Swift Kit for both professional and at-home uses, we will not sit on the sidelines while the FDA reviews our game changing technology, and are proceeding with separate efforts overseas. We have identified and interviewed distribution organizations for International territories including the Russian Federation where we are at the agreement drafting stage, a second territory that includes India, Malaysia, Singapore and Indonesia, also at the agreement drafting stage, and we have begun an interview process for a territory in the EU by talking to a UK based distributor and a group in Denmark associated with a large Euro based pharma. We also expect to interview several more EU based companies in the next several weeks.”
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 June 11, 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. ###