CorDx Achieves Emergency Use Authorization for Innovative Flu and COVID-19 Test

The U.S. Food and Drug Administration (FDA) has recently granted Emergency Use Authorization (EUA) to CorDx for its novel Tyfast Flu A/B & COVID-19 Multiplex Rapid Test. This marks a significant advancement in the diagnostic field, providing a quick and reliable tool for detecting and differentiating between influenza type A, influenza type B, and COVID-19 within just 10 minutes. Designed for professional use, this test is intended for point-of-care settings by healthcare professionals or trained individuals.

CorDx, known for its global leadership in developing and distributing medical diagnostics, emphasizes that this 3-in-1 multiplex test is a lateral flow immunoassay device that requires only a nasal swab sample. It is hoped that the test, currently authorized for in-vitro diagnostic use under EUA, will soon receive over-the-counter (OTC) authorization, expanding access to rapid diagnostic testing for communities and families.

With the surge in respiratory viruses, CorDx's Tyfast test offers a much-needed solution for labs and healthcare providers, delivering fast and precise results at the point-of-care. This facilitates efficient and accurate diagnostics amidst rising cases of influenza and COVID-19. The company's Founder and CSO, Aiiso Li, has expressed optimism about the test's future prospects and its ability to prioritize health at a community level.