FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use
Drug Approval

FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use

  • By IPP Bureau | February 26, 2025

Aptitude Medical Systems (Aptitude) announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix COVID/Flu multiplex test. This innovative test represents a major advancement in accessible molecular diagnostics.

The Metrix COVID/Flu test simultaneously detects and differentiates SARS-CoV-2, Influenza A virus, and Influenza B virus in 20 minutes. Authorized for over-the-counter (OTC) use, it can be utilized in any environment, including at home and in CLIA-waived point-of-care (POC) settings.

"Molecular diagnostics are the gold standard for accuracy, but traditional systems are expensive, slow, and force molecular to be greatly underutilized. Metrix changes all that," said Scott Ferguson PhD, CEO of Aptitude. "We built Metrix to dramatically expand the reach of molecular diagnostics by breaking cost and accessibility barriers. Our Metrix COVID/Flu test empowers individuals to get their own lab-quality results on the spot in their homes and enables healthcare providers to upgrade from existing molecular and antigen testing platforms while lowering total cost of care."

"COVID-19 and flu are the top respiratory health threats in the United States, driving tens of millions of urgent care visits annually," said Jackson Gong PhD, COO, "Healthcare providers often find traditional molecular testing too cumbersome and cost prohibitive, and instead resort to antigen tests which offer much lower clinical value. What makes Metrix so exciting for urgent care is that it truly solves the cost burden, allowing providers to deliver better medicine and improve the financial viability of their practices, on which over half of Americans depend. The Metrix COVID/Flu test is available nationwide through Aptitude and our distribution partners in collaboration with Sekisui Diagnostics."

The FDA-authorized Metrix COVID/Flu molecular test detects and differentiates COVID, Flu A, and B in 20 minutes. It may be used in home and CLIA-waived settings.

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