Co-Diagnostics, Inc. Initiates Clinical Evaluations for its At-Home and Point-of-Care Co-Dx PCR Home™ Platform

Rhea-AI Summary

Co-Diagnostics, Inc. (Nasdaq: CODX) announced the start of clinical evaluations for its at-home and point-of-care Co-Dx PCR Home™ platform, including an initial COVID-19 test. These evaluations aim to support submissions for regulatory approvals from the FDA and other bodies. The platform utilizes patented Co-Primer™ technology, offering advanced diagnostics for infectious diseases. No specific timeline for completion has been provided due to required patient enrollment. CEO Dwight Egan emphasized the significance of this milestone, highlighting over two years of R&D and the potential global impact of this innovative diagnostic technology.

Positive

• Initiation of clinical evaluations for Co-Dx PCR Home™ platform.
• Development backed by over two years of R&D and a dedicated team.
• Potential for significant global impact with advanced diagnostic technology.

Negative

• No projected timelines for completion of evaluations due to patient enrollment challenges.

SALT LAKE CITY, Feb. 22, 2023 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has commenced clinical evaluations for its at-home and point-of-care Co-Dx PCR Home™ platform and initial COVID-19 test, consisting of the clinical trials and analytical studies that are expected to support submissions to the United States FDA and other regulatory bodies.

The Company's real-time PCR platform has been developed for detection of infectious diseases in at-home and point-of-care settings, with anticipated multiplex panels to follow after receipt of the platform's initial regulatory authorization. Because the evaluations are dependent on identifying and enrolling a particular number of both symptomatic and asymptomatic COVID-19-positive and -negative patients at testing sites, the Company will not be providing projected timelines for completion at this time.

"The commencement of our clinical evaluations represents the achievement of a profound milestone for our Company," remarked Dwight Egan, CEO of Co-Diagnostics. "It is the culmination of a development process that spans over two years of research and development and has harnessed the expert skills of well over a hundred dedicated scientists, engineers, and support staff. The new at-home and point-of-care testing (POCT) platform represents a high degree of innovation that brings together the power of our patented Co-Primer™ technology coupled with other proprietary IP, setting a new standard for compact POCT that unlocks the multiplexing potential of real-time PCR.

"We believe this invention holds significant promise for the United States and around the world, including regions of the globe that have not previously had access to the quality-of-life advantages of inexpensive, powerful, accurate diagnostic technology. We are excited to begin these clinical evaluations and to leverage the power of our groundbreaking science in this new and revolutionary platform."

About Co-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a state-of-the-art diagnostics technology. The Company's technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR Home™ platform and to locate genetic markers for use in applications other than infectious disease.

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 of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements regarding initiation of clinical evaluations, FDA submission for approval of the new Co-Dx at-home/point-of-care PCR testing device, and that anticipated multiplex panels are expected to follow after receipt of the platform's initial regulatory authorizations. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by 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, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

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SOURCE Co-Diagnostics

FAQ

What is the purpose of Co-Diagnostics' clinical evaluations for CODX?

The clinical evaluations aim to support regulatory submissions for the Co-Dx PCR Home™ platform and initial COVID-19 test.

When did Co-Diagnostics announce the start of its clinical evaluations?

Co-Diagnostics announced the commencement of clinical evaluations on February 22, 2023.

What technology does the Co-Dx PCR Home™ platform utilize?

The platform utilizes patented Co-Primer™ technology for advanced diagnostic testing.

What are the expected outcomes of the clinical evaluations for CODX?

Expected outcomes include regulatory approval submissions and future multiplex panel developments.

Who is the CEO of Co-Diagnostics?

The CEO of Co-Diagnostics is Dwight Egan.