Anavasi Diagnostics® Information

We are experienced scientists, engineers, and business people working together to tackle a global challenge: detecting infection with COVID-19. Together, we are determined to help save lives by delivering rapid, precise, and inexpensive diagnostic tests. Our goal is to enable health care professionals to confidently provide lab-quality results in minutes instead of days so that patients can confidently know almost immediately whether they are positive -- or not. Our first product, The AscencioDx® Covid-19 Test and The AscencioDx® Molecular Detector, is designed to provide a precise diagnosis of COVID-19 in under 30-minutes (on average) instead of the 1-3 days that most testing services and physician offices now require for PCR testing. Using our patent-pending proprietary technologies, the AscencioDx diagnostic test is administered painlessly, in just seconds, with a lower-nasal swab. Our mission is to continue developing and marketing diagnostic test systems for diseases in addition to COVID-19 using our PCR- equivalent point-of-care diagnostic platform without the unnecessary delay, expense, or reliance on less-than-precise antigen testing. This is only the beginning. *The AscencioDx® Covid-19 Test and The AscencioDx® Molecular Detector have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.