Co-Diagnostics Completes Key Studies for FDA Submission of Upper Respiratory Test — Co-Diagnostics, Inc. (Co-Dx)

Event summary

Co-Diagnostics completed clinical and analytical studies for its Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test, enrolling over 1,400 patients across 9 sites.
Analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs.
The company plans to submit a Dual 510(k) and CLIA Waiver by Application to the FDA in Q3 2026.
The studies demonstrated consistent performance across multiple operators, sites, and instruments.

The big picture

Co-Diagnostics' completion of extensive clinical and analytical studies marks a critical step toward FDA clearance for its upper respiratory test. The move aligns with broader industry trends toward decentralized, near-patient diagnostic solutions, potentially expanding access to accurate PCR testing beyond traditional laboratory settings. Success in this submission could position Co-Diagnostics as a key player in the point-of-care diagnostics market.

What we're watching

Regulatory Timing: Whether the FDA will accept and clear the 510(k) submission by Q3 2026, as targeted.
Market Adoption: The pace at which Co-Diagnostics can commercialize the platform upon receiving regulatory clearances.
Competitive Positioning: How the company's point-of-care PCR diagnostics will compete in a market dominated by established players.