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FDA clears Aptitude's latest Metrix molecular dx to test for COVID
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Fusion42 · 18 September 2026 · Fusion42 review
The FDA granted Aptitude 510(k) clearance for its next-generation Metrix COVID diagnostic test, which offers three times greater sensitivity and 30% faster results compared to its original emergency use authorized test. The device is cleared for over-the-counter and professional use in CLIA-waived settings, and continues to be supported by HHS BARDA amid the upcoming termination of COVID-19 EUA policies.
This Wire brief sits within Fusion42's coverage of Medtech, and 5 sources have reported it between 16 Sep 2026 and 18 Sep 2026.
◆ ◆ The Wire takeaway
You face a widening market as Aptitude's cleared COVID test shifts from emergency to standard regulatory approval, opening doors in OTC and professional settings without interruption through EUA's end. Now is the time to engage with labs reliant on CLIA-waived devices before competitors fill the transition gap.
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5 sources · first reported 16 Sep 2026 · latest 18 Sep 2026
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