Co-Diagnostics submitted a dual 510(k) premarket notification and CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV multiplex respiratory test.
RT’s Three Key Takeaways:
- Regulatory Submission: Co-Diagnostics submitted a Dual 510(k) premarket notification and CLIA Waiver by Application to the Food and Drug Administration (FDA) for its multiplex respiratory test.
- Clinical Validation: The submission is supported by clinical studies involving more than 1,400 patients and an analytical program consisting of over 10,000 test runs.
- Point-of-Care Access: If granted, the CLIA waiver would permit the use of the PCR test in decentralized healthcare environments, increasing access to molecular testing outside of traditional laboratories.
Co-Diagnostics Inc has submitted a Dual 510(k) premarket notification and a concurrent Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application to the FDA for its upper respiratory multiplex test.
The Co-Dx PCR Flu A/B & RSV test is designed for use on the Co-Dx PCR Pro instrument. According to a news release from the company, the submission follows the completion of clinical and analytical performance studies.
“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,” said Dwight Egan, chief executive officer of Co-Diagnostics.
The submission is supported by clinical studies enrolling more than 1,400 symptomatic patients across nine geographically distinct US clinical sites. Additionally, the company conducted an analytical program spanning 27 studies and more than 10,000 upper respiratory PCR test runs, including a multicenter reproducibility study.
If the CLIA waiver is granted, it would enable the use of the test in decentralized, waived point-of-care settings. The company stated that the platform is designed to improve accessibility and affordability while using a cloud-based infrastructure to help track localized outbreaks as they occur.
The Co-Dx PCR platform, which includes the PCR Home, PCR Pro, and associated mobile app and tests, is currently subject to review by the FDA and is not yet available for sale.
