Co-Diagnostics Completes 27 Studies and 10,000 PCR Runs Before Q3 FDA Submission
CODX•Co-Diagnostics completed 27 analytical studies with over 10,000 PCR runs and enrolled 1,400 patients across nine US sites for its upper respiratory point-of-care test. The company plans a dual FDA 510(k) clearance and CLIA waiver submission in Q3 2026, moving it closer to commercial use of its Co-Dx PCR platform.
1. Completion of Analytical and Clinical Studies
Co-Diagnostics executed 27 individual analytical studies comprising over 10,000 PCR test cup runs to validate assay performance under controlled conditions. Concurrently, a clinical trial enrolled 1,400 symptomatic patients across nine geographically distinct US sites to assess real-world diagnostic accuracy for its upper respiratory test.
2. Planned FDA 510(k) and CLIA Waiver Submission
The company is preparing a dual submission package for FDA 510(k) clearance and a CLIA Waiver by Application, targeting Q3 2026. This coordinated regulatory strategy aims to secure both market authorization and waived status for point-of-care deployment.
3. External Reproducibility and Operator Testing
An external multicenter reproducibility study demonstrated consistent performance when operated by untrained users across multiple instruments and sites. These results support inclusion of reproducibility data required for the CLIA waiver, underscoring the platform’s ease of use in decentralized settings.
4. Commercialization Outlook for Co-Dx PCR Platform
Upon achieving FDA clearance and CLIA waiver, the Co-Dx PCR platform—including PCR Home, PCR Pro and mobile app interfaces—will be positioned for near-patient and point-of-care diagnostics. The milestone advances Co-Diagnostics toward its goal of decentralized PCR testing.
