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DECN Readies its GenViro! Covid-19 Swift Kits for Latest FDA Mandated Testing of both Saliva and Blood Protocols as it Enters Final Selection Process for a U.S. Based Testing Partner
DECN Readies its GenViro! Covid-19 Swift Kits for Latest FDA Mandated Testing of both Saliva and Blood Protocols as it Enters Final Selection Process for a U.S. Based Testing Partner.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"Company to Receive Production Sample Kits from its Contract Manufacturer for U.S. FDA Level Testing of Each Modality, Plus Additional Sample GenViro! Swift Kits for International Testing Needs LOS ANGELES, CA / ACCESSWIRE / July 23, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today announced it is immediately readying testing samples of its GenViro! Covid-19 Swift Kits for testing in the US market and additional testing internationally. One-half will be used in a blood-based testing protocol and the other half in a saliva-based testing protocol. Based on the results, the company will make a direct run for completion of the feasibility testing so that sales of GenViro! Swift kits can commence as soon as possible in select International markets in which the company has or shortly expects to have distribution agreements. The company is conducting a parallel "sister" study in Korea, and additional saliva testing will be completed for international distribution.DECN expects to receive the U.S. supply of production testing samples during the first week of August 2020 which is expected to coincide with the company's selection of an experienced US based clinical testing partner. The company has narrowed potential US testing partners to two clinical trials organizations and allied laboratories and expects to announce its decision in the next few days. That organization will lead the clinical trials in the U.S. that DECN expects will be the final requirement to secure FDA emergency authorization.The company plans a total of four studies, two covering feasibility for both the blood based and saliva based modalities, using as a foundation the most recent FDA guidelines for both blood and saliva-based testing, and two each covering the actual clinical testing. Once the feasibility testing is completed, the company will make any final adjustments that may be required to impedance wavelength. And through its European distributor(s) the company will be seeking European CE Mark certification. The CE registration is primarily a Good Manufacturing Practices (GMP) review, which is not as protracted as the FDA testing. Further, to register GenViro! Swift for CE Mark, DECN's feasibility testing will similarly meet the product registration needs of the recently announced Asian...