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DECN Signs Agreement With US-Based Laboratory as Testing Partner for Genviro! Saliva Swift Kit Testing for Additional FDA, EU CE Mark and Russian Federation Submissions
DECN Signs Agreement With US-Based Laboratory as Testing Partner for Genviro! Saliva Swift Kit Testing for Additional FDA, EU CE Mark and Russian Federation Submissions.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"FDA & CLIA certified laboratory will begin the testing of the Genviro! 10.5 Sec. Saliva Swift Kit, with full results expected to be reported to regulators in USA, EU and Russian Federation, and will also be included in the Genviro! Swift package inserts LOS ANGELES, CA / ACCESSWIRE / September 30, 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 it has signed an agreement with a certified US-based testing partner to undertake a feasibility study as well as required testing for FDA EUA and European Union CE Mark certification as well as with the Russian Federation for submission of the Genviro! Covid-19 Saliva Swift Kit. The company expects the lab to report its results to DECN, who will include these results in their upcoming FDA EUA applications in Q4 2020, as well as parallel applications with the EU and Russian Federation, as DECN continues its international efforts to make its detection technology available globally. The international product launch commenced on September 26, 2020 at the pricing previously announced. A large first order has been received."Coming on the heels of the announcement of having our first international distributor order in place as of September 26, 2020, I am encouraged that the signing of a testing partner in the US will accelerate our efforts to get the Genviro! Covid-19 testing technology authorized by the FDA and in the US market," said CEO Keith Berman. "Initially slated to be tested for professional use, once we secure FDA authorization we will make the push for our individual at-home use that requires much the same testing. That is what we and the rest of the world truly want to see. In anticipation of this, our instructional videos which we are distributing to the international markets were completed for both professional and at-home individual use. As I have repeatedly stated, the test strip and meter reader testing modality, upon which our Covid-19 testing technique is based, has been used by diabetics to test themselves worldwide for years, so we have every reason to believe that the GenViro! Saliva Swift Kit will be readily accepted in the professional and...