FDA Authorizes Aptitude Metrix COVID/Flu Multiplex Molecular Test for Home and Point-of-Care Use

Metrix® COVID/Flu multiplex test

© Aptitude Medical Systems, Inc.

Aptitude Medical Systems, Inc, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Metrix COVID/Flu multiplex molecular diagnostic test, broadening access to rapid, lab-quality results in both home and CLIA-waived settings, according to a company news release.¹

The Metrix COVID/Flu molecular test detects and differentiates SARS-CoV-2, influenza A, and influenza B in approximately 20 minutes, helping clinicians and patients expedite diagnosis and treatment decisions. The test’s expanded authorization for over-the-counter use further supports widespread, convenient testing, eliminating barriers often associated with traditional molecular platforms.

"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."¹

Respiratory viruses such as COVID-19 and influenza drive tens of millions of urgent care visits annually in the United States. While molecular testing offers higher clinical accuracy than antigen-based assays, cost and logistical constraints have limited its adoption in many outpatient and urgent care settings. The Metrix platform’s streamlined workflow and reduced costs may facilitate broader use of molecular diagnostics, potentially improving clinical care and workflow efficiency for healthcare professionals.

The Metrix COVID/Flu test is the second FDA-authorized assay on Aptitude’s next-generation molecular platform. Aptitude’s development pipeline includes additional diagnostics for various infectious and noninfectious conditions, aligning with the company’s goal to provide lab-quality results quickly and affordably.

Reference

1. Aptitude receives FDA authorization for Metrix COVID/Flu multiplex molecular test for point-of-care and over-the-counter use [news release]. Published February 24, 2025. Accessed February 24, 2025. https://prnmedia.prnewswire.com/news-releases/aptitude-receives-fda-authorization-for-metrix-covidflu-multiplex-molecular-test-for-point-of-care-and-over-the-counter-use-301983339.html