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DECN CEO Releases Open Letter on FDA At-Home COVID-19 Rapid Testing Guidelines Saying It's the Speed to Results Reporting and Certain Added Regulations That Need to Be Addressed
DECN CEO Releases Open Letter on FDA At-Home COVID-19 Rapid Testing Guidelines Saying It's the Speed to Results Reporting and Certain Added Regulations That Need to Be Addressed.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"CEO asks the critical questions, "We hear every day about new "rapid" tests, both in the press and from government officials, so I ask what is meant by the term "rapid," and moreover, how does a manufacturer or distributor deal with the new FDA at-home reporting requisites which counter the most long-awaited benefits of an at-home test - its anonymity"LOS ANGELES, CA / ACCESSWIRE / August 10, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, through its subsidiary Pharma Tech Solutions, Inc., today has released an "Open Letter" in support of the FDA's recent announcement of at-home rapid testing guidelines. DECN, in its Open Letter states that it's likely that debate will intensify over the definition of what a "rapid" kit is, as well as the new layer of regulatory requirements the FDA plans to add to at-home use products which for the first time includes regulations applicable to users of the kits, for such things as reporting to Federal agencies. DECN views these new regulatory layers as huge impediments to the future adoption of the Covid-19 at-home tests in the hands of the general public.According to DECN CEO Keith Berman, "While the actual testing requirements can be debated in terms of being too stringent and needing realignment, the fact is that we need to clearly define the meaning of "rapid" when we refer to Covid-19 testing, and then address the "hidden" regulatory requirements that could significantly slow and inhibit such testing. The current reporting required by the FDA guidelines and red tape requirements are a serious impediment and present significant sticking points to getting a truly rapid at-home point-of-care test in the public's hands anytime soon."For example, the FDA has only released at-home testing guidelines for molecular self-testing and not for serological or direct antigen based tests. As a leading provider of diabetic testing kits for two decades and an early applicant for FDA EUA authorization of its testing kits, the company's testing overseas is showing that both Covid-19 Swift Kits, for blood and saliva, complete their assays in 10.5 seconds or less, proving that true "rapid" testing is achievable. And, because our testing is based on our diabetes testing model ...