Co-Diagnostics has filed a Dual 510(k) premarket notification with the US Food and Drug Administration (FDA) for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test, run on the Co-Dx PCR Pro instrument.
The molecular diagnostics company submitted a CLIA Waiver by Application at the same time. If the FDA grants the waiver, the test could be used in decentralised waived point-of-care settings rather than only in conventional laboratories.
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Co-Diagnostics said this would help widen access to molecular PCR [polymerase chain reaction] testing outside traditional laboratory environments.
Neither the test nor the wider Co-Dx PCR platform is currently available for sale. The solution, which includes the PCR Home and PCR Pro instruments, a mobile app and associated tests, remains subject to review by the FDA and other regulatory bodies.
The filing follows the company’s earlier announcement that it had finished the clinical and analytical performance studies underpinning the test.
The clinical study enrolled more than 1,400 symptomatic patients at nine geographically distinct clinical sites in the US. The analytical programme covered 27 separate studies and more than 10,000 upper respiratory PCR test runs, including work carried out to support the CLIA waiver request.
Among the analytical studies was an external multicentre reproducibility study, which assessed performance across several operators, sites and instruments. According to the company, the study showed consistent results when the test was operated by untrained users at multiple locations.
Co-Diagnostics CEO Dwight Egan said: “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 decentralised 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.”
Co-Diagnostics describes the Co-Dx PCR platform as pairing real-time PCR quality with a lower-cost instrument and consumable model.
The system also uses a cloud-based infrastructure with data aggregation, which the company says is intended to help track localised outbreaks as they happen.
Co-Diagnostics said these features set the platform apart from existing decentralised and point-of-care molecular systems and support its move into near-patient and decentralised testing environments.
When it reported the completion of the studies last month, the company said a Dual 510(k) and CLIA Waiver by Application submission to the FDA was targeted for the third quarter of 2026.
Based in Utah, Co-Diagnostics develops, manufactures and markets diagnostics technologies based on the detection and analysis of nucleic acid molecules, either DNA or RNA.
It uses its proprietary technology to design tests for its Co-Dx PCR at-home and point-of-care platform, and to identify genetic markers for uses beyond infectious disease.
