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.