All of our available tests are either currently approved under the FDA’s Emergency Use Authorization (EUA) or are pending FDA EUA approval. Tests that are pending EUA have been submitted to the FDA by the manufacturer and are in review by the FDA. In accordance with FDA regulations, tests that are pending EUA approval can be distributed and used in the U.S. under the supervision of a high complexity CLIA licensed laboratory. Inspire Diagnostics has partnered with a number of CLIA laboratories to administer any tests that require such oversight.
Our Access Bio CareStart COVID-19 Rapid Antigen Test is currently FDA EUA Approved for use in point-of-care settings under a CLIA certificate of waiver. Our Boditech COVID-19 Rapid Antibody Test is currently pending FDA EUA approval.