The near-term commencement of clinical studies is expected to align with recent WHO tuberculosis recommendations for near-point-of-care molecular testing and utilizing tongue swab samples
New recommendations are aligned with the design of Co-Dx's proprietary test, platform, and mission
SALT LAKE CITY, March 25, 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 that it has commenced shipments of PCR Pro® instruments*, Co-Dx™ PCR MTB test kits* for tuberculosis ("TB"), and proprietary sample preparation instruments to its joint venture CoSara Diagnostics Pvt. Ltd. ("CoSara") in India. These materials are necessary to begin clinical performance studies of the TB test on the PCR platform, as the Company completes final steps toward initiating those studies in the near term.
According to the World Health Organization’s (“WHO”) 2025 Global tuberculosis report, the global TB incidence rate was only reduced by 12% since 2015, compared to the WHO's End TB Strategy target reduction rate of 50%. On March 9, the WHO issued recommendations for the first time on near-point-of-care ("NPOC") molecular diagnostics and easy-to-collect tongue swabs for patients who cannot produce sputum samples, in order to expand access to TB testing and help close critical diagnostic gaps.
The Company's PCR testing platform* and NPOC TB test kit are already aligned with this new guidance.
Co-Diagnostics CEO Dwight Egan remarked, "We are pleased that our foresight in designing the Co-Dx PCR testing platform and TB test for broad accessibility in point-of-care and near-point-of-care settings, and to be operated with either sputum or tongue swab samples, is consistent with the direction of the WHO's recommendation. The WHO's recommendation underscores the importance of these technological advances in molecular diagnostics to ensure early and accurate TB testing. Co-Diagnostics' mission to develop and increase access to life-saving PCR tests is aligned to fulfill that objective."
Despite achieving a 21% reduction in TB incidence since 2015, India continues to account for approximately 25% of global cases according to the 2025 Global tuberculosis report.
Mr. Egan continued, "The Co-Dx PCR MTB test has continued to generate encouraging third-party preclinical results, supporting further clinical evaluation. We recently announced that the PCR Pro® instrument received a license from the CDSCO to be manufactured and sold as a medical device instrument, and expect to announce the commencement of clinical performance studies in India in the near future as we prepare for a submission to the Indian regulatory authorities for clearance."
*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: the expected benefits of the WHO's recommendation for NPOC TB tests and tongue swab sample types; the expected timing and initiation of clinical performance studies; the Company's plans to pursue regulatory submissions and potential clearances in India and other jurisdictions; the anticipated performance and potential clinical utility of the Company's PCR platform and TB test; and the Company's broader strategy for global deployment and adoption of its PCR platform. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management as of the date of this release. Such statements are subject to a number of risks and uncertainties, including, without limitation: risks related to the Company's ability to obtain necessary regulatory approvals in multiple jurisdictions; the timing and results of clinical studies; uncertainties associated with market acceptance and adoption of the Company's products; the ability to successfully establish and manage distribution relationships; the Company's ability to manufacture and supply its products, including through third-party partners such as CoSara; competitive dynamics in the global molecular diagnostics market; execution risks associated with international expansion; and general economic, geopolitical, and public health conditions in the regions in which the Company operates or intends to operate. 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 27, 2025, 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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