Co-Diagnostics seeks FDA clearance for COVID-19 Test and diagnostic instrument

Co-Diagnostics, Inc. (Nasdaq: CODX), a pioneering molecular diagnostics company, has reached a pivotal milestone by completing its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance. This application pertains to both the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 Test intended for over-the-counter (OTC) use.

The submission was made through the FDA’s electronic Submissions Template And Resource (eSTAR) system, an initiative aimed at streamlining and standardizing medical device submissions. The FDA has acknowledged the receipt of the 510(k) application, marking the first step towards potential approval.

The Co-Dx PCR platform is designed to democratize the access to high-quality diagnostic testing, traditionally available only in complex clinical laboratories. The platform features a compact, robust real-time PCR instrument that can be operated in point-of-care settings or at home via a simple smartphone interface. This innovative approach uses test cups equipped with patented Co-Dx Co-Primers® technology, aiming to bring gold-standard PCR diagnostics to a wider audience.

In addition to seeking approval for the COVID-19 test, Co-Diagnostics is preparing to pursue clearance for the same test for point-of-care testing (POCT) applications. The company is also advancing diagnostics for other diseases, including tuberculosis, human papillomavirus, strep A, and a comprehensive respiratory multiplex test capable of detecting influenza A and B, COVID-19, and RSV in a single assay.

Dwight Egan, CEO of Co-Diagnostics, expressed the significance of this FDA application as a critical step in the company’s evolution and its efforts to bridge the diagnostic access gap globally. “This FDA application represents a crucial step towards closing the gap that separates many patients and communities around the world from gold-standard diagnostics,” Egan stated. He emphasized that 510(k) clearance would not only enhance the credibility of the Co-Dx PCR platform but also facilitate the expansion of the company’s diagnostic offerings to other regions and indications.

While the company is poised to begin commercialization of the COVID-19 test upon clearance, it is also progressing rapidly to meet the clinical and regulatory requirements for other diagnostic tests. These developments are expected to be transformative, leveraging the platform’s versatility and state-of-the-art technology to meet diverse global health needs.