COMPANY BEGINS SCALE PURCHASES OF GENVIRO!™ COMPONENTS, CREATING PACKAGING USING FDA EUA LABELING GUIDANCE, APPLICATION IN PROCESS FOR GENVIRO!™ AT-HOME SCREENING KIT
LOS ANGELES, CA / ACCESSWIRE / April 7, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc. the manufacturers and design specifiers for the GenViro! Covid-19 Swift Kit, is an 18-year old, diabetes and now disease testing bio-technology development 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, announces today that the company has received the Pre-EUA Acknowledgement letter from the U.S. FDA for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit. This grant by the FDA is a major milestone in our GenViro!™ Covid-19 test kit development, now beginning its 7th week since we became aware that our manufacturer and R&D professionals were living and working at Ground Zero of the Korean Covid-19 epidemic.
DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020. Later on this same day FDA counsel had several exchanges with FDA EUA staff. In one of those exchanges, the FDA provided Guidance for our final product testing.
Keith Berman, CEO of Decision Diagnostics commented, “We filed our final application with the FDA for EUA approval on April 3, 2020, taking out all reference to our at-home use Covid-19 kit. We submitted the application late in the afternoon EDT, and incredibly we received our Pre-EUA Acknowledgement the morning of April 4, 2020, less than 24 hours later, and on the weekend. We were so stunned by the rapid acknowledgment that we waited almost two days to inquire whether the acknowledgment was what we have come to know as the “Pre-EUA.” We were assured that this letter from the FDA and the device serial number assigned are exactly what we had been hoping for.”
As early as Saturday April 4, it was clear that the FDA review staff was aware that our methodology was different than those slower and older methods that had received FDA EUAs, or were in review. Although the testing requested will be rigorous, it appears that testing will require 30 known Covid-19 positive samples and 30 known Covid-19 negative samples, all samples based on venous blood. The company is now looking to contract with a hospital or commercial laboratory to complete this testing.
Mr. Berman continued, “Upon receipt of these acknowledgments from the FDA, we contacted our partners in Korea, and provided specifications for all of the major components required for the GenViro!™ kit that are not used or a part of our GenUltimate! TBG product. Today our partners began ordering these components to begin build, assembly and bench testing for the post-prototype version of GenViro!™, Point of Care kit. These activities will become part of the completion of our Design Specifications file and Design History file for Genviro!™, and are necessary components of all FDA cleared medical devices. “
The company plans to discuss in the coming days how we intend to identify the various coronaviruses through GenViro!™. Reading that discussion will be a unique opportunity. The method the company intends to use will be based upon earlier products shepherded by Messrs. Berman and Musho. We expect industry people will be surprised.
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, the GenUltimate! (“Sunshine”) diabetes test strip, its GenAccord! Enhance (“Caterpillar”) strip and meter systems for the uninsured and under-insured, its GenChoice! (“Ladybug”) test strip now in the later stages of FDA 510(k) prosecution, and its GenUltimate! Precis products manufactured for International markets are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With new 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!TM product designed to test for the Coronavirus Covid-19, is not yet available in the United States or Puerto Rico but Emergency Waivers are in process. Now that we are a part of FDA review, and the product concept which had been presented to officials in Washington, DC is now part of the review and approval process.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of April 6, 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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