EXCLUSIVE: Co-Diagnostics Completes Clinical and Analytical Studies of Upper Respiratory Point-of-Care Test Ahead Of FDA Submission Planned

Co-Diagnostics Inc. (NASDAQ: CODX ) on Wednesday said it completed 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.

Completes Studies For PCR Respiratory Test The molecular diagnostics company currently expects to include the studies in its planned submission package.

The update on these studies represents a significant milestone in preparation for a Dual 510(k) and CLIA Waiver by Application submission to the U.S.

Food and Drug Administration (FDA), targeted for the third quarter of 2026. "Completing both the analytical and clinical performance studies for the upper respiratory test is a significant execution milestone for Co-Diagnostics," said Dwight Egan, CEO of Co-Diagnostics.

Read Also: EXCLUSIVE: Co-Diagnostics Ships Diagnostic Tests To India Ahead Of TB Study Launch "The FDA 510(k) and CLIA Waiver by Application processes require substantial analytical and clinical evidence, and the depth of the work our team has completed, including 27 individual analytical studies, over 10,000 PCR test cup runs, and a clinical study enrolling more than 1,400 symptomatic patients…We are targeting submission in Q3 2026 and remain confident in our path to clearance." Analytical And Clinical Validation Supports Planned FDA Filing Prior to IVD test submission to the FDA for review, medical device manufacturers are required to complete extensive analytical and clinical validation studies to demonstrate that the test performs reliably under both controlled laboratory conditions and its intended real-world use.

Analytical validation of the Co-Dx PCR test included over 10,000 PCR test cup runs across 27 individual studies, including studies supporting the CLIA Waiver by Application to allow the test to be used in waived point-of-care settings.

This also included a rigorous external multicenter reproducibility study demonstrating consistent performance when operated by untrained operators across multiple sites and instruments.

Co-Diagnostics Continues To Expand Commercial And Diagnostic Programs In March, Co-Diagnostics signed an agreement for CoSara Diagnostics Pvt.

Ltd, to expand its commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka.

The expansion significantly increases CoSara’s addressable market across South Asia, bringing the total regional opportunity to an estimated $13 billion based on internal analyses and third-party market data.

In May, the company completed the assay development strategy for the Bundibugyo virus (BDBV), causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda.

CODX Price Action: Co-Diagnostics shares were down 0.65% at $3.08 during premarket trading on Wednesday.

The stock is near its 52-week low of $1.26, according to Pro data.

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