Dual-assay strategy designed to support outbreak response and surveillance efforts in affected regions
Potential blood-based Ebola assay would represent an important expansion of Co-Dx™ PCR point-of-care platform capabilities
SALT LAKE CITY, June 2, 2026 /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 continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"). The program includes development of both a pan-Ebola assay designed to rapidly detect multiple ebolavirus species and a multiplex assay capable of differentiating among Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses currently associated with outbreaks in Central Africa.
This dual-assay strategy is intended to provide flexibility in supporting outbreak response efforts, including those of potential NGO partners, subject to future development, validation, regulatory review, and deployment requirements.
"Our ability to rapidly develop and deploy molecular diagnostic solutions for emerging infectious disease threats is one of the most important differentiators of the Co-Dx platform," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "The progress we are making with Ebola reflects not only the flexibility of our assay design capabilities, but also the value of the international infrastructure we have built through CoSara. As outbreaks emerge around the world, combining rapid assay development with localized manufacturing and deployment capabilities positions us to respond quickly when new diagnostic needs arise."
The Ebola PCR assay workflow configurations also being developed to support point-of-care environments for the Co-Dx PCR point-of-care platform* would represent the first blood-based pathogen assay designed for use on the Co-Dx PCR Pro®. This would significantly expand the platform's capabilities beyond swab-based infectious disease testing and increase the range of potential applications that may be addressed through future menu expansion.
Mr. Egan continued, "Many of the world's most serious infectious diseases are identified using blood samples, and expanding the platform to support those applications would represent an important step forward for Co-Diagnostics. The ability to bring rapid, high-quality PCR testing closer to patients, whether through respiratory, tuberculosis, HPV, or blood-borne disease applications, supports our broader goal of making molecular diagnostics more accessible in both developed and emerging markets."
*The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet 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) and to identify genetic markers for use in applications other than infectious disease.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will," "seeks," "anticipates," and similar expressions, or the negative of these terms. Forward-looking statements in this press release include, but are not limited to, statements regarding: (i) the Company's ability to execute its assay joint development strategy for Ebolavirus tests with CoSara Diagnostics; (ii) the potential future development, validation, regulatory review, commercialization, manufacture, and distribution of the tests; (iii) the Company's ability to rapidly respond to emerging infectious disease threats; (iv) the potential utility, effectiveness, and adoption of the Co-Dx PCR platform for decentralized diagnostics and outbreak monitoring, including for blood-borne pathogens; and (v) potential collaborations with governmental and non-governmental organizations relating to infectious disease preparedness and response. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks that market demand or public health conditions may change; risks related to the Company's ability to successfully develop, validate, obtain regulatory authorization or approval for, manufacture, and commercialize any Ebola assay or related products; risks related to regulatory review by the FDA or other regulatory authorities; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform; risks associated with dependence on third parties, suppliers, collaborators, and distribution partners; risks related to competition, technological change, and intellectual property protection; and other risks described from time to time in the Company's filings with the Securities and Exchange Commission ("SEC"). Actual results may differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements. A further description of risks and uncertainties can be found in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2026, and in its other filings with the SEC. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.
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SOURCE Co-Diagnostics
