Aptitude Receives FDA Authorization for Metrix® COVID/Flu Multiplex Molecular Test for Point-of-Care and Over-the-Counter Use

SANTA BARBARA, Calif., Feb. 24, 2025 /PRNewswire/ -- Aptitude Medical Systems, Inc. (Aptitude) today 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."

About Aptitude: Aptitude is a pioneering deep-tech healthcare company revolutionizing infectious disease detection and treatment. Its mission is to democratize diagnostics by providing actionable lab-quality results, anywhere, in minutes. The Metrix COVID/Flu test is the second FDA-authorized molecular test on the platform. Aptitude has an extensive development pipeline to deliver on this mission for a wide range of health and wellness conditions.

This work is funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00013.

To learn more, visit www.aptitudemedical.com, follow Aptitude on LinkedIn.

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SOURCE Aptitude Medical Systems, Inc.