Business
DECN Issues Support for Recently Announced FDA COVID-19 At-Home Testing Template as the Company's Submission for Its Genviro! Swift COVID-19 At-Home Test Kit Anticipated Many of the New FDA Requisites
DECN Issues Support for Recently Announced FDA COVID-19 At-Home Testing Template as the Company's Submission for Its Genviro! Swift COVID-19 At-Home Test Kit Anticipated Many of the New FDA Requisites.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"FDA Commissioner Dr. Stephen Hahn says, "These types of tests will be a game changer"LOS ANGELES, CA / ACCESSWIRE / August 3, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, through its subsidiary Pharma Tech Solutions, Inc., today announced its support for the recently issued FDA Covid-19 At-Home Use Template saying it, "Contains much of what was in our May 1st At-Home Application to the FDA." The company says it is 100 percent behind the issuance of at-home testing guidelines, and that it is now preparing to amend its first EUA submission PEUA200947, for its GenViro! Blood Swift Kit for at-home use. Shortly thereafter we anticipate filing a separate EUA application with the FDA for its GenViro! Saliva Swift Kit for home use. Both applications for the home use of GenViro! Swift are expected to meet the new FDA template, the FDA's first such template issued by the FDA. No Covid-19 home-based test kits have as yet been authorized by the FDA, although several at-home specimen collection kits have been authorized. Nonetheless, experts universally agree that routine at-home testing of people who may be asymptomatic can be transformative in the effort to significantly slow the spread. Current at-home specimen collection kits do not provide at-home point of care testing."As we have repeatedly stated, the FDA has moved the goalposts on a variety of testing and use matters so we welcome their settling on these first at-home testing guidelines, especially since our previously filed application appears to have correctly anticipated a lot of what they would eventually require," said DECN CEO Keith Berman. "We have always concurred with Commissioner Hahn that convenient and affordable at-home testing will be a game changer, providing the potential for screening on a daily basis if desired. All versions of our GenViro! Swift test kits are true point of care devices, whether the point of care is in the home, at the office, or are administered by a professional. This allows for screening for the virus on site, anywhere, anytime and will help people get back to work, or attend school, board an airplane, go to a social event, attend a house of worship, and visit loved ones, including those with assisted living arrangements, all as restrictions are lifted, with a much greater se...