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DECN Finalizes FDA Pre-EUA Version of Its Genviro! Screening Covid-19 Swift Kit, Providing Results in 15 Seconds Using Only 1.0-2.0 Microliters Whole Blood
DECN Finalizes FDA Pre-EUA Version of Its Genviro! Screening Covid-19 Swift Kit, Providing Results in 15 Seconds Using Only 1.0-2.0 Microliters Whole Blood.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"COMPANY'S EMERGENCY USE (EUA) APPLICATION TO BE UPDATED IN THE NEXT WEEK AS MANUFACTURING SPECIFICATIONS FINALIZED, DISCUSSION OF GENVIRO! UNIQUE QUALITIES ENSUESLOS ANGELES, CA / ACCESSWIRE / March 23, 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, and its GenViro! Rapid Kits for the real time testing for the Coronavirus (COVID-19) now seeking FDA Emergency Waiver (EUA).Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip that will go into production just as soon as the FDA grants emergency status to the DECN product. The company's methodology employs a simple, easy to use, swift (15 seconds and faster than Rapid) method for determining the presence of a virus in blood lyced into blood plasma. Blood sample requirements are 1-2 microliters. The kits will be manufactured for DECN in Korea by its contract manufacturer, the same company that manufactures our diabetic test strips. While the manufacturing will occur in Korea, the test strip is 100% of American design.Keith Berman, CEO of DECN commented, "The news channels are filled with talk about the coming rapid test kits for the detection of the virus Covid-19. These kits are recent creations based on traditional chemistry methods such as anti-body/antigen analysis or PCR (the nose swab RNA method). While these methods offer a path to results, we have not found any that will give a patient a result in less than minutes (and we have our doubts), or are methods that can provide on the spot analysis.Further these methods and variations of same, typically require analyzers that are in the instrument arsenals of large hospitals or large commercial laboratories, not the shopping center parking lo...