Co-Diagnostics submits 510(k) applications for platform, OTC COVID-19 test

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Molecular diagnostics firm Co-Diagnostics submitted its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for its Co-Dx PCR Pro instrument, along with the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.

The Co-Dx polymerase chain reaction (PCR) system consists of a compact real-time PCR instrument operated in point-of-care (POC) settings or at-home settings via an intuitive smartphone interface, using test cups powered by Co-Dx Co-Primers technology.

In a statement, the Salt Lake City-based Co-Diagnostics said that it is also preparing to apply for 510(k) clearance for its Co-Dx PCR COVID-19 for POC testing on the Co-Dx PCR Pro system. Other diagnostics being developed for the platform or in preparation for clinical evaluations include tests for tuberculosis, HPV, and strep A, as well as a respiratory multiplex that detects influenza A and B, COVID-19, and RSV in a single test.

"This FDA application is an important milestone in our Company's growth and represents a crucial step towards closing the gap that separates many patients and communities around the world from gold-standard diagnostics," Co-Diagnostics CEO Dwight Egan said.

"If granted, we believe that the credibility of 510(k) clearance for diagnostic use would greatly validate the quality of our new platform as we proceed with the completion of tests for other indications and for use in other regions of the world.”

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