Co-Diagnostics, Inc. files the first FDA 510(k) application for the Co-Dx PCR Pro platform

The Company expects that the OTC application will be followed shortly by an application for POC approval, and other tests are in preparation to meet the needs of the global market

SALT LAKE CITY, June 14, 2024 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq: CODX) (the “Company” or “Co-Dx”), a molecular diagnostics company with a unique, patented platform for developing molecular diagnostic tests, today announced that the Company has filed its first application with the U.S. Food and Drug Administration ( FDA) for 510(k) approval for the Co-Dx™ PCR Pro™ Device and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.

Co-Diagnostics completed the application through the FDA’s Electronic Templates and Resources (eSTAR) system and received confirmation of receipt of the 510(k) application from the FDA. eSTAR provides a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed to prepare a 510(k) application.

The Co-Dx PCR platform is designed to help bridge the gap in access to infectious disease diagnostics by facilitating widespread decentralization of the gold standard PCR diagnostics, which has historically been found only in high-complexity clinical laboratories. It consists of a compact and rugged real-time PCR device, operated in a healthcare facility or at home via an intuitive smartphone interface, with test cups powered by patented Co-Dx Co-Primers® technology.

The company is also preparing to soon obtain approval for the Co-Dx PCR test for the Covid-19 virus on a new device that will be used in point-of-care tests (POCT).

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

“This FDA filing is an important milestone in our company’s development and is a key step towards closing the gap that separates many patients and communities around the world from the highest level of diagnostics,” he said Dwight Egan, Company’s head director. “We believe that if 510(k) approval is granted, credibility for diagnostic applications will significantly validate the quality of our new platform as we complete testing in other indications and for use in other regions of the world.

“While we have identified markets for this initial diagnostic offering and look forward to commencing commercialization once approval is granted, we expect other future tests to be even more transformative and we are rapidly approaching requirements to initiate clinical trial evaluations and submit the required documents for these tests in the appropriate target markets.”

*The Co-Dx PCR Platform (including PCR Home™, PCR Pro™, mobile app and all associated tests) is subject to review by the FDA and/or other regulatory authorities and is not yet available for sale. The Co-Dx PCR Pro device and the Co-Dx Covid-19 test are currently under review by the FDA.

About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah Corporation, is a molecular diagnostics company that develops, produces and sells cutting-edge diagnostic technologies. The Company’s technologies are used for tests aimed at detecting and/or analyzing nucleic acid molecules (DNA or RNA). The company is also using its proprietary technology to design specific tests for the Co-Dx PCR platform for home and point-of-care use and to locate genetic markers for applications beyond infectious diseases.

Forward-looking statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes”, “expects”, “estimates”, “intends”, “may”, “plans”, “will” and similar expressions or the negative thereof. Such forward-looking statements are based on facts and conditions existing at the time they are made and expectations as to future facts and conditions. Forward-looking statements included in this release include statements regarding our intention to obtain approval for the POCT COVID-19 test kit on a new instrument in the near future, as well as our plans to initiate clinical evaluations and complete regulatory filings for the remaining tests in our pipeline. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from the results anticipated or anticipated in such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis, or at all, due to certain risks and uncertainties found in the disclosure of risk factors in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC). regarding March 14, 2024and in our other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements relating to the matters discussed in this press release, except as required by applicable securities laws.

SOURCE Co-diagnosis