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DECN's GenViro!(TM) COVID-19 "Rapid" Kit to Reap Huge Boost from 3/16 FDA Guidance Allowing for Near Immediate Distribution of Kits Prior to Emergency Waiver Grant
DECN's GenViro!(TM) COVID-19 "Rapid" Kit to Reap Huge Boost from 3/16 FDA Guidance Allowing for Near Immediate Distribution of Kits Prior to Emergency Waiver Grant.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"Significant regulatory policy is changed so that once diagnostic validation is completed, test kits can be distributed subject only to certain labeling and testing presentationsLOS 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/downloadKeith 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 ...