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DECN Provides Progress Update on Major Events for Its GenViro! Saliva Swift Kits for the Detection of COVID-19
DECN Provides Progress Update on Major Events for Its GenViro! Saliva Swift Kits for the Detection of COVID-19.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"Includes International Distribution Status, Professional Video Finalized, XPRIZE Contest Next Steps, Manufacturing and Signed Testing Partner UpdatesLOS ANGELES, CA / ACCESSWIRE / October 13, 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 provided the following "Progress Update" on its continuing efforts to secure FDA EUA approval for its Covid-19 Saliva Swift Kit antigen test, its international distribution status and other company developments.Late last month the company announced it had signed an agreement with an FDA and CLIA certified US-based testing partner to undertake a feasibility study together with 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 lab results will be included in DECN's upcoming FDA EUA applications which are expected to be filed in Q4 2020. The company plans for parallel applications with the EU and Russian Federation, as it continues its international efforts to make its detection technology available globally."Based on the testing conducted by our Korean partner, we have every reason to believe that our US testing partner will see similar results and report that GenViro! meets (and is likely to exceed) the FDA requirements to earn EUA approval," said CEO Keith Berman. "We are encouraged by the progress and pace the company is seeing on a variety of critical fronts and remain focused on bringing each to a successful conclusion as swiftly as possible to further our overall goals of bringing this promising testing solution to markets globally."In addition to the upcoming FDA testing, the company announced it has received its first written purchase order from an Indian distributor. The first of several expected follow-up orders turned out to be substantially larger than initially reported, and is comprised of 500,000 Genviro! Saliva Swift Kits, 50,000 GenViro! Swift Verify Kits and 7,500 GenViro! Swift Kit Meters. The company expects manufacturing to commence shortly and additional opportunities for product distribution in Malaysia, Indonesia, t...