Wow. Nothing but good news in here:
Quote:"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-negative reporting."
Berman further stated, "The current testing will also allow us to do the final programming of algorithms for the GenViro! Swift Kit meters, fixing the version level at version 1.7. We will also be enhancing our meters with the ability to provide a qualitative measure of certain probabilities. This additional meter feature, version 2.1, is expected to be implemented early in 2021. We will expand on that capability in subsequent announcements as more results become available and are validated. With all of this data available in approximately 10 seconds, at the actual point of care or testing, we believe now more than ever that we have what will turn out to be the most desirable technology available for rapid and reliable Covid detection."
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