Full Press Release Details
The Australian patent represents the first patent granted for the Company's new point-of-care testing platform
SALT LAKE CITY,Dec. 29, 2025/PRNewswire/ --Co-Diagnostics, Inc.(Nasdaq:CODX)("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the Australian Patent Office has grantedAustralian Patent No. AU2022270084A1, strengthening Co-Dx's intellectual property portfolio surrounding its novel Co-Dx PCR platform*.
Initially filed in May 2022 before being granted in June of this year, the patent is the first granted for the new platform and provides broad protection in Australia for the Company's proprietary system and methods used for nucleic acid detection and analysis. The claims specifically cover the design and operation of the Co-Dx PCR Pro™ instrument and test cups, including its approach to performing high-quality polymerase chain reaction (PCR) testing outside of traditional laboratory environments.
"This patent represents another significant milestone in securing global protection for our technology as we continue expanding the potential applications of the point-of-care PCR platform," said Dwight Egan, CEO of Co-Dx. "From the beginning, Co-Dx's goal has been to make accurate, accessible PCR testing available where it is needed most, and strengthening our global IP portfolio is essential to that mission."
The patent grant in Australia also provides strategic protection in a region where Co-Dx and potential commercial partners may choose to introduce or distribute the Co-Dx PCR platform in the future. Australiarecently experienceda record-breaking flu season, and securing patent coverage in the market serves as a key defensive measure to protect the commercial potential of the platform, including the Co-Dx PCR Flu A/B, COVID, RSV multiplex test (currently in clinical performance testing).
Co-Diagnostics' Co-Dx PCR platform is designed to deliver gold-standard PCR accuracy in a compact, user-friendly device suitable fordecentralizedtesting environments. The platform leverages the Company's patented Co-Primers® technology and is intended to enable rapid, sensitive, and specific molecular diagnostics across a broad range of infectious disease applications.
*The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.
About Co-Diagnostics, Inc.:Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are 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 at-home and point-of-care platform (subject to regulatory review and not currently for sale) to identify 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. Forward-looking statements include, but are not limited to, statements regarding the anticipated benefits of the Australian patent grant, the potential applications, performance, commercialization, and market opportunities of the Co-Dx PCR platform and related tests, the progress and outcomes of clinical performance testing, the prospects for regulatory review or approval by the FDA or other regulatory authorities, and the Company's ability to introduce or distribute its products in Australia or other markets, whether independently or with commercial partners. 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 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 27, 2025, 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.
SOURCE Co-Diagnostics