FDA clears Aptitude’s latest Metrix molecular dx to test for COVID

MedTech FDA clears Aptitude’s latest Metrix molecular dx to test for COVID By Joseph Keenan Sep 18, 2026 8:55am FDA approval COVID-19 HHS BARDA molecular diagnostics The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency use authorized test. The diagnostic, which can fit in a hand, is now cleared for over-the-counter and professional use in CLIA-waived (Clinical Laboratory Improvement Amendments) settings, the company said. The latest Metrix dx was supported by the U.S.

Health and Human Services’ Biomedical Advanced Research and Development Authority. “We're continually developing Metrix to make it better,” JP Wang, Aptitude’s co-CEO, said in a statement. “FDA clearance is an important step, not a stopping point.

We continue to push the Metrix platform forward with faster tests, better performance, simpler operations, and a broader menu for our growing customer base” Related End of the EUA era: FDA begins to wind down emergency authorizations for COVID-19 tests Its approval comes prior to the HHS move to terminate COVID-19 Emergency Use Authorization (EUA) on December 26, and the company said it doesn’t expect any disruptions to product availability during the upcoming respiratory season. During the transition period ahead of the EUA policy termination, all previously distributed Metrix products can continue to be used based on their expiration dates. Aptitude's Metrix COVID/Flu test is currently under FDA review for 510(k) clearance.

The Goleta, California, dx maker is also working on expanding its platform to include products that target RSV (respiratory syncytial virus), strep and sexually transmitted infections. Those diagnostics are either in late-stage development or under FDA review, it said. FDA approval COVID-19 HHS BARDA molecular diagnostics Diagnostics MedTech