Trxade Group, Inc. Withdraws Its Previously Filed FDA Emergency Use Authorization for Rapid COVID-19 Testing Kit

TAMPA, FL -- Trxade Group, Inc. (NASDAQ: MEDS), an integrated drug procurement, delivery and healthcare platform, announced today that its wholly-owned subsidiary, Integra Pharma Solutions, LLC, has formally withdrawn its Emergency Use Authorization (EUA) application in connection with its partner’s manufacture of the SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit from consideration in response to U.S. Food and Drug Administration (FDA) guidance. The decision to withdraw the EUA application was made after much discussion with its partnered manufacturer. Per FDA guidance, only one EUA application is allowed per manufactured kit product. The EUA process is typically filed by manufacturers and there are specific guidelines that must be adhered to by the manufacturer, one of which includes reporting on test performance. Although Integra Pharma Solutions initially filed the EUA itself in collaboration with the manufacturer, in order to expedite the review and approval process, the parties now believe it makes more sense for the manufacturer to submit its own EUA application directly and for Integra Pharma Solutions to withdraw its previously filed EUA application. 

In its ongoing effort to combat this pandemic, Integra Pharma Solutions has secured additional manufacturer relationships for test kit products for distribution, thus ensuring adequate distribution channels to continue supplying healthcare facilities and authorized providers (which meet the required criteria to perform tests) with test kits. All products carried by Integra Pharma Solutions are sourced from manufacturers that have submitted EUA applications for consideration.