Orange County-based medical diagnostic company Fluxergy has taken the next step toward getting a high-speed test for COVID-19 available for use. Fluxergy submitted an emergency use authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s test system as a COVID-19 diagnostic at the point-of-care. Advanced rapid point-of-care tests for COVID-19 may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy’s on-site sample- to-answer test for COVID-19 requires a very small sample, typically a nasal swab, which is mixed with a reagent solution, loaded onto a card and inserted into the analyzer in a two-step procedure. In this episode of DeviceAlliance’s Medtech Radio we with speak CCO of Fluxergy, Dr. Ali Tinazli. He also serves as Business Partner & Strategy Advisor with Immunaccel, and is a Member of the Strategic Advisory Board of InnVentis Ltd. Join us as we discuss Fluxergy's goal to make laboratory testing accessible everywhere, the challenges facing current labs, and how our current environment is acting as a catalyst for the next generation of medical device innovation.
