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.

"We're continually developing Metrix to make it better," said JP Wang, Co-CEO of Aptitude. "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."

Metrix COVID/Flu Test Moving Toward 510(k) Clearance

Aptitude's next-generation Metrix COVID/Flu Test is also currently under FDA review for 510(k) clearance, continuing the company's transition of its respiratory portfolio from emergency authorization to traditional FDA clearance.

This transition is occurring as the COVID-19 EUA declarations for medical devices are scheduled to terminate on December 26, 2026, following the announcement from the U.S. Department of Health and Human Services.

Aptitude does not anticipate disruption to Metrix product availability during the upcoming respiratory season. Metrix is broadly available through major distributors in collaboration with Aptitude's commercial partner, Sekisui Diagnostics, while Aptitude continues the regulatory transition of its respiratory portfolio.

Consistent with FDA transition policies, customers can continue purchasing Metrix products as the transition progresses, and all previously distributed Metrix EUA-authorized products may continue to be used through their labeled expiration dates.

Expanding Access to Molecular Testing

Aptitude is building Metrix into a broader molecular diagnostics platform, with additional products targeting RSV, Strep, and sexually transmitted infections in late-stage development or under FDA review. That menu expansion is occurring alongside rapid commercial adoption of the Metrix platform, particularly in urgent care. Over the past year, hundreds of clinics have adopted the platform.

Metrix was purpose-built for decentralized healthcare settings, especially urgent care, where molecular testing has historically been limited by high upfront costs, fixed testing capacity, large footprints, workflow complexity, and purchasing commitments. By removing many of those barriers, Metrix makes molecular diagnostics practical in settings where traditional molecular systems have often been difficult to deploy.

"The opportunity is much larger than replacing existing molecular systems," said Scott Ferguson, Co-CEO of Aptitude. "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."

About Aptitude

Aptitude develops molecular diagnostic products designed to make high-quality testing accessible wherever it is needed. Its Metrix platform combines molecular performance with simple workflows, compact instrumentation, rapid results, and economics designed for broad deployment.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract 75A50123C00013.

To learn more, visit www.aptitudemedical.com and follow Aptitude on LinkedIn.

SOURCE Aptitude Medical Systems, Inc.