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Aptitude Announces FDA 510(k) Clearance of Next-Generation Metrix® COVID Test
First Metrix 510(k) clearance introduces improved sensitivity and speed as Aptitude grows its molecular diagnostics platform
GOLETA, Calif., Sept. 16, 2026 /PRNewswire/ — Aptitude today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the next-generation Metrix® COVID Test, marking the company's first FDA 510(k) clearance and the continued expansion of the Metrix molecular diagnostics platform. Development was supported by the Biomedical Advanced Research and Development Authority (BARDA).
Metrix was designed to make high-performance molecular testing dramatically more accessible. Small enough to hold in your hand, Metrix is FDA-cleared for both over-the-counter and professional use in CLIA-waived settings. The next-generation Metrix COVID Test represents a substantial advancement over the original EUA-authorized product, delivering approximately 3-fold greater analytical sensitivity and 30% faster results.
FDA Clears Next-Generation Metrix COVID Test Delivering 3-Fold Higher Sensitivity
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Aptitude Medical Systems’ next-generation Metrix COVID Test.
The clearance represents the first FDA 510(k) clearance for Aptitude and expands the regulatory footprint of its Metrix molecular diagnostics platform, the company announced. Development of the assay was funded in part by federal support from the Biomedical Advanced Research and Development Authority (BARDA), an agency within the Administration for Strategic Preparedness and Response in the US Department of Health and Human Services.
The handheld system is cleared for both over-the-counter use and professional use in CLIA-waived point-of-care settings. Compared to the original emergency use authorization (EUA) version, the next-generation assay provides approximately 3-fold higher analytical sensitivity and 30% faster results, according to the manufacturer.
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