Decision Diagnostics, Westlake Village, Calif, through its subsidiary Pharma Tech Solutions, Westlake Village, Calif, 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 United States 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 United States-based clinical testing partner. That organization will lead the clinical trials in the United States 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. And through its European distributor(s) the company will be seeking European CE Mark certification.
“Although we have just passed the 120-day mark in the journey to get to this point, we are confident we are ready to conduct the revised FDA level testing required to gain emergency authorization approval here in the US,” says Keith Berman, DECN CEO. The company will be updating its Pharma Tech Solutions website to demonstrate in more detail the contents of the GenViro! Swift test kits.
For more information, visit Decision Diagnostics.