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DECN to Add 2nd Covid-19 Test Kit Using Antibody/Antigen Methodology as a Determination Test for Patients Who Previously Tested Positive for Covid-19
DECN to Add 2nd Covid-19 Test Kit Using Antibody/Antigen Methodology as a Determination Test for Patients Who Previously Tested Positive for Covid-19.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"COMPANY TO AGAIN SEEK FDA EUA FOR ITS CONFIRMATION KIT MAKING DECN THE FIRST TO OFFER TWO TYPES OF COVID-19 TEST KITS, A SCREENING KIT AND A POST SCREEN CONFIRMATION KIT LOS ANGELES, CA / ACCESSWIRE / March 25, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) is an 18-year old, diabetes-focused bio-technology development firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! ("Sunshine") diabetes test strip, its GenAccord! Enhance ("Caterpillar") strip and meter systems for the uninsured and under-insured, its GenChoice! ("Ladybug") test strip now in the later stages of FDA 510(k) prosecution, and its GenUltimate! Precis products manufactured for International markets, and its GenViro! Rapid Kits for the real time testing for the Coronavirus (COVID-19) now seeking FDA Emergency Waiver (EUA).Today, DECN announces that the company, through its advanced development team in Korea, has arrived at a second Covid-19 test methodology, a modified Serology method, that at the completion of documentation, be put through the FDA Emergency Waiver (EUA) process. This second kit will begin assembly for internal testing on April 1, with availability in late summer 2020. The method will again use a Biosensor (test strip-like device) and the company's Precise meter.Keith Berman, CEO of DECN commented, "When we began exploring available testing methods for the Covid-19 virus, our goals were straight forward. Provide an easy to use, reliable, inexpensive test kit, designed for immediate use at the point of care, and eventually for at-home use. We accomplished these goals with our GinViro! Swift kit. And now we turn our attention to a second method for confirmation of those people who test positive during the Covid-19 screen. This second method will be true to our technology. GenViro! Confirm will be of our own creation and engineering and make use of our deep experience in Biosensors. This confirmation kit will have a wholesale price of $9.95. We will provide a kit unit forecast in coming days."GenViro! Confirm will produce confirmatory results in less than a minute, also based on a small finger prick blood sample. The method is safe, effective, and its biggest benefit to ...