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DECN GenViro! Trial Using Human Saliva Donors for Its Swift Test Kits Proceeds Directly to FDA Level Testing As COVID-19 Product Testing Enters “Home Stretch”
DECN GenViro! Trial Using Human Saliva Donors for Its Swift Test Kits Proceeds Directly to FDA Level Testing As COVID-19 Product Testing Enters “Home Stretch”.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"With Favorable Testing Results Anticipated on November 13 From Our FDA and CLIA Certified Laboratory, DECN Estimates Completion and Filing of 3rd FDA EUA Application in the Next 3 WeeksLOS ANGELES, CA / ACCESSWIRE / November 12, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters through its subsidiary Pharma Tech Solutions, Inc., today announced its donor study has entered its final stages, and that having yielded better and quicker than anticipated results a separate feasibility study will not be required. The company is now actively testing known positive and negative Covid-19 patients in an effort to finish its FDA EUA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed. We are reviewing drafts of this application currently. The donor study will provide exact data requirements for FDA EUA, EU CE Mark and Russian Federation applications for the GenViro! Saliva Swift Kit for the detection of Covid-19."Testing for GenViro! has been so encouraging that on Tuesday, November 10, 2020 our certified testing lab partner informed us that we can avoid doing two studies and instead move to direct patient testing of positive and negative Covid-19 human samples required for FDA submission. That's taking place right now" said CEO Keith Berman. "As such, we have been informed that testing is in the "home stretch," and we estimate an FDA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed."Berman continued "The testing of positive and negative human saliva samples is demonstrating a number of critical findings. One such finding concerns the identification of sample results where we anticipate positive results to be just that, positive, and the identification of negative results to also be just that, negative. In marked contrast to the expected GenViro! Swift Kit result reporting, there are popular testing methods currently on the market that have what we consider largely unacceptable false-negative rates. Numerous news articles have confirmed this. We have also commented on this. The FDA is paying particular attention to the incidence of false-negati...