Summary: Co-Diagnostics has completed its first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 Test for over-the-counter use.

Key Takeaways:

  1. FDA Application: The submission was completed via the FDA’s eSTAR system and acknowledged by the FDA.
  2. Access to Diagnostics: The Co-Dx PCR platform aims to decentralize PCR diagnostics, making them more accessible outside high-complexity labs, including at-home and point-of-care settings.
  3. Future Plans: Co-Diagnostics plans to pursue clearance for other diagnostic tests, including those for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex detecting multiple pathogens, to broaden their market reach and impact.

Co-Diagnostics, a company developing molecular diagnostic tests, announced the company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.

Submitting to the FDA

Co-Diagnostics completed the submission via the FDA’s electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation.

Improving Infectious Disease Diagnosis

The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with test cups powered by patented Co-Dx Co-Primers technology.

The company is also preparing to shortly pursue clearance for the Co-Dx PCR COVID-19 test on the new instrument, to be used for point-of-care testing (POCT).

Other diagnostics for the platform in varying stages of development or preparation for clinical evaluations include tests for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex that detects influenza A and B, COVID-19, and RSV in a single test.

Further reading: Co-Diagnostics Inaugurates Manufacturing Facility for New Molecular Diagnostic 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,” says Dwight Egan, the company’s CEO. “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. While we have identified markets for this initial diagnostic offering and we are eager to begin commercialization once cleared to do so, we expect that the other tests to follow will be even more transformative, and we are quickly moving to complete the requirements to initiate clinical evaluations and submit regulatory filings for these tests in their respective target markets.”

*The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.