Co-Diagnostics Joint Venture CoSara Provides Ebola Test Kits for Analytical Studies
Rhea-AI Summary
Co-Diagnostics (Nasdaq: CODX) reported two Ebola-related developments. Joint venture CoSara Diagnostics has supplied 200 SARAGENE Bundibugyo Virus Test kits to a third-party lab for analytical studies after a request from India’s Centre for Cellular and Molecular Platforms (C-CAMP), which supports India’s diagnostics preparedness.
The analytical work is expected to evaluate the assay’s limit of detection, repeatability, and reproducibility. Separately, Co-Diagnostics completed a proof-of-concept study of an extraction-free Co-Primers Ebola test on the Co-Dx PCR Pro point-of-care instrument using diluted plasma, described as the platform’s first blood-borne assay. CoSara is also developing a second-generation pan-Ebola assay for broader species detection. According to the company, the Co-Dx PCR platform and associated tests remain subject to regulatory review and are not yet available for sale.
Positive
- 200 Bundibugyo tests requested and supplied for analytical studies
- First blood-borne Ebola assay proof-of-concept on Co-Dx PCR Pro
- Analytical studies to evaluate limit of detection, repeatability, reproducibility
- CoSara developing second-generation pan-Ebola assay for broad species detection
Negative
- Co-Dx PCR platform and tests not yet available for sale, pending regulatory review
Market Reaction – CODX
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Company also completes proof of concept for the first blood-borne test for Ebola on Co-Dx PCR Pro ® instrument
The Company also announced successful completion of a proof-of-concept study evaluating an extraction-free Co-Primers® Ebola test on the Co-Dx PCR Pro® instrument* using diluted plasma as a sample type. This feasibility work represents the first blood-borne assay designed for use on the PCR Pro point-of-care instrument.
"Both of these updates represent key milestones in strengthening our readiness for emerging global viral threats," said Dwight Egan, Co-Diagnostics' Chief Executive Officer. "The recent Ebola outbreak in
Mr. Egan continued, "We are pleased with our teams' rapid response to a request from Indian public health authorities, as well as the exciting new development in the Co-Dx PCR platform capabilities which we believe has the potential to 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."
The analytical studies, which are expected to support evaluation of the assay's limit of detection, repeatability, and reproducibility, were initiated following a request by C-CAMP for 200 of CoSara's Bundibugyo tests. C-CAMP's InDx 2.0 National Diagnostics Catapult was launched in 2023 to proactively boost
CoSara's centralized-laboratory Bundibugyo test was built using the Company's patented Co-Primers technology, targeting one of the species that causes Ebola virus disease and is responsible for the current outbreaks in East and
*The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review or authorization by applicable regulatory authorities in the jurisdictions in which clearance or approval is sought, including the
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 Company's or its joint venture's plans and ability to complete analytical studies for the Bundibugyo virus test, the timing, design and results of those studies, to develop and validate a pan-Ebola assay, and to expand the Co-Dx PCR platform's capabilities to plasma-based sample types and future menu expansion. 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 or its joint venture's ability to successfully validate centralized laboratory Ebola tests in India or on the Co-Dx PCR platform; risks related to the Company' or its joint venture's ability to achieve regulatory clearance and commercialize the tests or the platform in strategically important markets, including risks that distribution partners may not successfully market, promote, or sell the Company's products; risks associated with international operations, including changing regulatory requirements, economic conditions, reimbursement environments, import/export restrictions, and foreign currency fluctuations; risks related to regulatory review by regulatory authorities that would be required to achieve a successful commercial launch; risks related to the performance, reliability, and market acceptance of the Co-Dx PCR platform and other Co-Dx technology; 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