Point-of-Care Multiplex PCR Test Submitted to FDA for Flu A/B and RSV Detection

(Co-Dx; Salt Lake City, UT, USA) has submitted the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test for use on the Co-Dx PCR Pro instrument through a Dual 510(k) premarket notification with a concurrent CLIA Waiver. The filing follows completion of clinical and analytical performance studies intended to support authorization. The test consolidates influenza A, influenza B, and RSV detection into a single point-of-care workflow on the company’s PCR platform.

The Co-Dx PCR platform combines real-time PCR quality with a lower-cost instrument and consumable model to facilitate deployment near the patient. The system integrates a cloud-based infrastructure with data aggregation features designed to help track localized outbreaks as they occur. These characteristics are positioned to distinguish the platform from existing decentralized and point-of-care molecular systems.

The submission includes a CLIA Waiver by Application. If granted, it would permit use in decentralized CLIA‑waived point‑of‑care settings and broaden access to molecular PCR testing outside traditional laboratory environments. The platform, including PCR Home, PCR Pro, the mobile app, and associated tests, remains subject to regulatory review and is not currently available for sale.

Supporting evidence includes a clinical study enrolling more than 1,400 symptomatic patients at nine geographically distinct U.S. clinical sites. The analytical program comprised 27 studies and more than 10,000 upper respiratory PCR test runs. A multicenter reproducibility study evaluated performance across multiple operators, sites, and instruments.

“The submission of this 510(k) premarket notification and CLIA Waiver by Application represents one of the most significant milestones in Co-Diagnostics' history and reflects years of investment in developing the Co-Dx PCR platform. With this submission, we are entering the next phase of our regulatory pathway as we move towards our goal of bringing decentralized PCR diagnostics closer to the patient through a platform designed to improve accessibility, affordability and ease of use, with a cloud-based infrastructure built to power situational awareness as infections spread through communities,” said Dwight Egan, Chief Executive Officer of Co-Diagnostics.