Business
DECN to add GenViro! Saliva Covid-19 Swift Kit :10.5 for Professional and Home Use Testing, Providing an Alternative Modality to its Finger Stick Methodology
DECN to add GenViro! Saliva Covid-19 Swift Kit :10.5 for Professional and Home Use Testing, Providing an Alternative Modality to its Finger Stick Methodology.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"Company will offer choice of Covid-19 Kits to be sold Internationally, and then in the U.S. after receipt of FDA Authorization, as Saliva Based Kit is not anticipated to require changes to GenViro! Swift Test Strip or Meter except for Software AdditionLOS ANGELES, CA / ACCESSWIRE / July 10, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) through its subsidiary Pharma Tech Solutions, Inc., today announced it plans to provide a new single-use saliva testing kit option to its professional and individual use finger stick GenViro! Covid 19 Swift Kits designed to identify Covid-19 viral load. Test reporting for the GenViro! finger stick kits are currently producing results at :10.5 seconds, and initial testing completed on the saliva version of the kit should yield even faster results since the saliva testing will not require any sample correction. The GenViro! Saliva Covid-19 Swift Kit is non-invasive. In consultation with the FDA, the company will either work to supplement its two current EUA applications, device (serial number) PEUA200232, GenViro! Covid-19 Swift Kit for professional use in commercial and group settings and device (serial number) PEUA200947, GenViro! Covid-19 Screening Kit for individual at-home use, or file two new applications.Preliminary testing, some illustrated below, was run using saliva from human donors and indicated that the saliva exhibits a comparable, and in fact favorable, impedance curve profile when compared to whole blood. In addition, saliva does not contain hematocrit (an abundance of or non-abundance of red blood cells) which on our whole blood based product required adapting our patent-pending TBG technology to the GenViro! test strip. Smooth and linear impedance curves are critical because our methods are designed to measure viral load at specific impedance frequencies (see Graph 1: Phase) and then report this load factor (see Graph 2: Magnitude). Data was compiled at our South Korean contract manufacturing and product development site at DECN's request.Initial feasibility testing of the saliva modality proved extremely positive.The company's two EUA applications are currently under FDA review while final interviews to select a clinical trial partner, needed to meet FDA new data foundations are in motion. The first task of the clinical trials organization is to produce a detailed clin...