More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs Analytical data to support concurrent 510(k) submission with CLIA Waiver by Application for point-of-care settings, with submission targeted for Q3 2026 SALT LAKE CITY, July 1, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced the completion of clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument* that the Company currently expects to include in its planned submission package. Completion of these studies represents a significant milestone in preparation of a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration ("FDA"), targeted for Q3 2026.
