California-based deep-tech healthcare startup Aptitude has received 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation Metrix COVID Test.
This marks the company’s first FDA 510(k) clearance and the continued expansion of its Metrix molecular diagnostics platform.
The company said Metrix, developed with support from the Biomedical Advanced Research and Development Authority (BARDA), was designed to make high-performance molecular testing dramatically more accessible.
Small enough to hold in the hand, the Metrix COVID Test is FDA-cleared for both over-the-counter and professional use in CLIA-waived settings. The test can be used with saliva or swab samples for at-home and over-the-counter testing without physician supervision.
According to Aptitude, the test offers approximately three times greater analytical sensitivity and delivers results 30% faster than the company’s original Emergency Use Authorization (EUA)-authorised product.
“We’re continually developing Metrix to make it better. FDA clearance is an important step, not a stopping point. We continue to push the Metrix platform forward with faster tests, better performance, simpler operations, and a broader menu for our growing customer base,” said JP Wang, Co-CEO of Aptitude.
Aptitude’s next-generation Metrix COVID/Flu Test is currently under FDA review for 510(k) clearance. The company said this forms part of its transition of its respiratory testing portfolio from emergency authorisation to traditional FDA clearance.
The transition comes ahead of the scheduled termination of COVID-19 EUA declarations for medical devices on December 26, 2026, following an announcement by the US Department of Health and Human Services.
Aptitude is also expanding the Metrix platform, with additional molecular tests targeting respiratory syncytial virus (RSV), strep and sexually transmitted infections in late-stage development or under FDA review.
The company said adoption of the Metrix platform has grown rapidly, particularly in urgent care, with hundreds of clinics adopting the system over the past year.
Designed for decentralised healthcare settings, Metrix aims to address some of the barriers associated with traditional molecular testing, including high upfront costs, fixed testing capacity, large instrument footprints, workflow complexity and purchasing commitments.
“The opportunity is much larger than replacing existing molecular systems. By removing the economic and operational barriers that have historically limited molecular testing, Metrix can bring molecular diagnostics into healthcare settings where it previously wasn’t practical,” said Scott Ferguson, Co-CEO of Aptitude.
