The 510(k) clearance marks the platform’s shift from emergency authorization to traditional clearance ahead of federal EUA termination dates.
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.
“We’re continually developing Metrix to make it better,” says JP Wang, co-CEO of Aptitude, in a release. “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.”
Portfolio Regulatory Transition
The clearance comes as medical device manufacturers prepare for the formal conclusion of pandemic-era emergency declarations. According to Aptitude, COVID-19 EUA declarations for medical devices are scheduled to terminate on Dec 26, 2026, following guidance from the US Department of Health and Human Services.
In line with this timeline, Aptitude reported that its next-generation Metrix COVID/Flu Test is currently under FDA review for 510(k) clearance. The company stated that it does not anticipate supply interruptions during the upcoming respiratory season. Metrix products remain available through major medical distributors under a commercial partnership with Sekisui Diagnostics. In accordance with FDA transition policies, clinical customers may continue purchasing products as reviews proceed, and previously distributed EUA-authorized units remain valid for use through their labeled expiration dates, the company noted.
Menu Expansion in Decentralized Settings
Aptitude is expanding the Metrix test menu beyond respiratory single-target testing, with additional assays covering respiratory syncytial virus, Streptococcus, and sexually transmitted infections currently in late-stage development or under active FDA review, according to a company release.
Aptitude reported that hundreds of clinics, particularly urgent care centers, have adopted the handheld system over the past year. The platform was designed to reduce barriers historically associated with decentralized molecular testing, including footprint constraints, workflow complexity, fixed capacity limits, and capital purchasing requirements, according to the announcement.
“The opportunity is much larger than replacing existing molecular systems,” says Scott Ferguson, co-CEO of Aptitude, in a release. “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. We believe Metrix can fundamentally expand where and how molecular testing is used.”
Photo caption: Metrix COVID Test
Photo credit: Aptitude Medical Systems
