Co-Diagnostics has completed clinical and analytical performance studies for its Co-Dx PCR Flu A/B and RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument.
The milestone supports the company’s planned dual U.S. FDA 510(k) and CLIA Waiver by Application submission, targeted for the third quarter of 2026. The Co-Dx PCR platform and associated tests remain subject to regulatory review and are not yet available for sale.
This is relevant because respiratory infections often present with overlapping symptoms. Influenza A, influenza B and respiratory syncytial virus can require different management decisions, while rapid identification can support appropriate care, infection control and antiviral use.
Point-of-care molecular testing is especially important in settings where treatment decisions need to be made quickly. Near-patient PCR platforms aim to bring laboratory-level molecular testing closer to clinics, urgent care centres and other decentralised care settings.
Co-Diagnostics said its analytical validation work included more than 10,000 PCR test cup runs across 27 studies. These studies included evidence intended to support CLIA Waiver by Application, which would allow the test to be used in waived point-of-care settings if authorised.
The company also completed a clinical study involving more than 1,400 symptomatic patients across nine geographically distinct U.S. clinical sites. The scale of the clinical study is important because respiratory diagnostics must perform reliably across real-world patient populations and care settings.
A separate external multicentre reproducibility study evaluated whether test performance could be replicated across different operators, sites and instruments, including untrained operators. This is particularly relevant for CLIA-waived settings, where tests must be simple and reliable enough for use outside high-complexity laboratories.
The target product is part of Co-Diagnostics’ broader Co-Dx PCR platform, which includes the PCR Pro instrument, mobile app and associated tests. The company’s approach is built around its patented molecular diagnostic technology for detecting nucleic acids.
