Significant regulatory policy is changed so that once diagnostic validation is completed, test kits can be distributed subject only to certain labeling and testing presentations
LOS ANGELES, CA / ACCESSWIRE / March 18, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) is an 18-year old, diabetes-focused bio-technology development firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for 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.
Today, DECN announces that the company is revising strategies (and forecasts) for its GenViro!™ Covid-19 test kit, a test kit that provides a coronavirus result in less than a minute, at the point of case. The company expects that it will receive a major boost from the most recent and thus far most optimistic FDA guidance for Coronavirus test kits.
On March 16, the FDA updated its COVID-19 test policy. A significant change to this policy is that once validation testing for a product has been completed, the test can be distributed to customers, entities and users, with certain labeling and a summary of test results provided on the company website (and/or the package). GenViro!™ has been validated at the company’s R&D center in Daegu, Korea for the H5N1 virus and most recently the methodologically similar corona virus. The new FDA policy is available to read at: https://www.fda.gov/media/135659/download
Keith Berman, CEO of DECN commented, “In the last 24 hours we have witnessed a sea change in how the FDA is processing applications for Covid-19 diagnostic kits, and in doing so is allowing some of these kit products to be sold or provided once test validation is provided. While the company will still need to provide ample data and a full discussion of its unique technology in the coming days, the new FDA policy will provide a channel that will allow the company to manufacture test kits and put these kits into distribution almost immediately. This same unperturbed policy will also allow us to quickly add our second GenViroTM product designed for hospitals and for clinics and commercial labs desirous of a confirmatory method for those who test positive for coronavirus.”
Mr. Berman concluded, “I have been in and around the in-vitro diagnostics business for over 40 years, and never before in all of that time, have I witnessed a policy like this. This latest guidance from the FDA shaves months from our product development process, and we all shall reap these benefits. Tomorrow we will discuss our new plans going forward now that we will shortly be a two product coronavirus diagnostics company.”
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 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, and the product concept has been presented to officials in Washington, DC by invitation.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of March 17, 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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