Co-Diagnostics Inc. to Submit Enhanced COVID-19 Test for FDA 510(k) Clearance

In a move towards improving its diagnostic offerings, Utah-based molecular diagnostics firm Co-Diagnostics Inc. has announced its decision to submit an improved version of its COVID-19 test for 510(k) clearance to the U.S. Food and Drug Administration (FDA). The company made this decision following an interactive dialogue with the regulatory body and in light of findings from a recent clinical evaluation.

Originally, Co-Diagnostics had filed a 510(k) application for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™. However, following discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test related to shelf-life stability, the firm decided to withdraw the submission. The company now aims to put forth an enhanced version of the original test, which addresses the issues that surfaced during the 510(k) review.

The new Co-Dx PCR COVID-19 test will undergo a 510(k) OTC evaluation process following the completion of relevant clinical evaluation data collections. This updated test will also incorporate the company’s most recent platform developments, which is expected to lead to significant operational and manufacturing efficiencies.

As part of its broader development strategy, Co-Diagnostics is also working towards introducing new tests for conditions such as tuberculosis, upper-respiratory multiplex, and various human papillomavirus strains. The enhanced version of the PCR COVID-19 test is considered a key stepping stone in the execution of the firm’s comprehensive development and commercialization plans for the Co-Dx PCR platform.

However, it’s crucial to note that the Co-Dx PCR platform which includes the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software, is still subject to review by the FDA and/or other relevant regulatory bodies and is currently not available for sale.

About Co-Diagnostics Inc.
Co-Diagnostics is a renowned provider of molecular diagnostics solutions. Primarily, the firm develops, manufactures, and markets advanced diagnostic technologies which are primarily designed using detection and/or analysis of nucleic acid molecules (DNA or RNA). Its proprietary technology is used to design specific tests for the Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Co-Diagnostics’s 8K filing here.

Co-Diagnostics Company Profile

Co-Diagnostics, Inc, a molecular diagnostics company, develops, manufactures, and sells reagents used for diagnostic tests that function through the detection and/or analysis of nucleic acid molecules in the United States and internationally. The company offers Co-Dx PCR platform, a polymerase chain reaction (PCR) testing to patients in point-of-care and at-home setting.