#United States #Salt Lake City #Co-Diagnostics #PCR Test #FDA 510(k)

Co-Diagnostics Completes Clinical Studies for FDA Submission

Co-Diagnostics, Inc., a molecular diagnostics firm based in Salt Lake City, has announced a remarkable milestone in its path to FDA approval for its upcoming upper respiratory point-of-care test. The company has completed extensive clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B RSV multiplex test using the Co-Dx PCR Pro® instrument. This significant achievement positions the company for a dual 510(k) submission alongside a CLIA Waiver by Application, targeted for Q3 2026.

In total, the study enrolled more than 1,400 symptomatic patients across nine distinct clinical sites within the United States. To ensure the reliability of its testing procedures, Co-Diagnostics conducted an impressive number of analytical tests—over 10,000 ranging from 27 individual studies. These efforts reflect the company's dedication to providing high-quality diagnostic solutions that can meet the demands of real-world healthcare settings.

Dwight Egan, the Chief Executive Officer of Co-Diagnostics, emphasized the significance of completing these studies. In his words, "Completing both the analytical and clinical performance studies for the upper respiratory test is a significant execution milestone for Co-Diagnostics." Egan further explained that the rigorous testing is critical to gaining FDA approval and demonstrating the test's reliability under both laboratory and realistic usage conditions.

The analytical validation performed by the company incorporated over 10,000 PCR test cup runs across a wide variety of experiments. Among these studies, one notable external multicenter reproducibility study demonstrated the test's consistency when administered by various operators in different locations and using multiple instruments. This study is particularly vital for acquiring a CLIA Waiver, which would allow the test to be utilized in waived settings, enhancing its accessibility in clinical environments.

Egan elaborated on the reproducibility study, stating, "The reproducibility study was designed to evaluate whether performance observed in clinical settings could be replicated across different operators, sites, and instruments. The results support inclusion of those data in our planned FDA submission," reinforcing the reliability of their diagnostic solutions.

This is an encouraging development as the need for accurate and efficient respiratory diagnostics grows, especially given the challenges presented by various respiratory illnesses, including Flu and RSV. The platform developed by Co-Diagnostics is specifically designed to achieve high performance standards, making it suitable for decentralized settings.

It's important to note that while the Co-Dx PCR platform, which also includes PCR Home®, PCR Pro®, and associated tests, shows promise, it is still undergoing regulatory review. Once approved, it aims to transform the capabilities of near-patient PCR diagnostics significantly.

As the healthcare landscape evolves, having rapid and accurate diagnostic tests available will be crucial. Co-Diagnostics is setting the stage to play a key role in this transformation within the healthcare system that not only seeks efficiency but also reliability in testing outcomes.

With the FDA targeted submission approaching in Q3 2026, the healthcare community is keenly watching to see how Co-Diagnostics’ innovations could potentially reshape respiratory diagnostics in clinical care, making these tests more accessible to healthcare providers and patients alike. This journey marks an exciting chapter in the ongoing quest for actionable health solutions.