Co-Diagnostics, Inc. Plans to Submit Upgraded COVID-19 Test to FDA for Clearance

Co-Diagnostics, Inc. Moves Forward with Enhanced COVID-19 Test Submission

Co-Diagnostics, Inc. (Nasdaq-CM: CODX), a leading molecular diagnostics company, has announced its intention to submit an enhanced version of its COVID-19 test for 510(k) clearance to the U.S. Food and Drug Administration (FDA). This strategic decision follows constructive discussions with the FDA regarding the test's shelf-life stability. As a result, the company is withdrawing its previous 510(k) application to focus on developing a more robust version of the test.

The Co-Dx PCR COVID-19 Test, used on the PCR Pro instrument, aims to provide accurate detection of the virus while improving its reliability and performance based on clinical evaluations. The company expressed satisfaction with the collaboration and feedback received from the FDA, noting that it facilitated the development of a better product.

Reasons for Withdrawal of Previous Submission

The withdrawal of the existing application comes after particular concerns were raised regarding the stability of one of the test components. The FDA's feedback highlighted potential issues related to the test's shelf-life, prompting Co-Diagnostics to prioritize a submission that addresses these concerns comprehensively. By enhancing the test, Co-Dx aims to ensure that it meets the necessary standards for both safety and efficacy.

Following the modification, Co-Diagnostics plans to resubmit for 510(k) clearance. This new testing iteration will incorporate recent advancements in the Co-Dx PCR platform, ultimately streamlining manufacturing processes for both COVID-19 tests and future diagnostic applications.

Future Developments and Additional Testing

The company's roadmap does not just stop at an enhanced COVID-19 test; Co-Diagnostics envisions a comprehensive suite of diagnostic tools. They anticipate rolling out additional tests for other diseases, such as tuberculosis and human papillomavirus (HPV), after the improved COVID-19 product gains regulatory approval. These expansions exemplify the company’s commitment to innovation and its goal of creating a versatile diagnostic platform for various at-home and point-of-care testing needs.

Co-Diagnostics has established itself as a key player in the molecular diagnostics sector, leveraging proprietary technology to produce tests that effectively detect nucleic acid sequences. With its focus on developing advanced diagnostic solutions, the company maintains its position at the forefront of public health responses, particularly amid ongoing challenges presented by infectious diseases.

A Commitment to Safety and Efficiency

Inherent in Co-Diagnostics’ mission is an unwavering commitment to the health and safety of the public. By addressing the regulatory feedback thoroughly and taking proactive steps towards enhancement, the company exemplifies a dedication to efficiency in manufacturing and operational processes. The integration of next-generation technologies into the COVID-19 testing framework is a strategic move aimed at solidifying their market position while maintaining high standards of public health safety.

In conclusion, the announcement from Co-Diagnostics regarding their upgraded COVID-19 test is a significant development not only for the company but also for public health efforts in combating the ongoing pandemic. The anticipation surrounding the next submission and forthcoming tests highlights Co-Diagnostics' role as an innovator in molecular diagnostics.

About Co-Diagnostics, Inc.

Co-Diagnostics, Inc. is a molecular diagnostics company based in Utah, specializing in state-of-the-art diagnostic technologies. The company's proprietary solutions focus on the detection and analysis of DNA and RNA, aiming to contribute significantly to public health through innovative testing solutions. As Co-Diagnostics continues to grow, its expansion into various diagnostic areas signals a robust future in improving healthcare outcomes worldwide.