Co-Diagnostics Advances Ebola PCR Assay Development Strategy with Joint Venture CoSara
Joint development strategy has been developed to address international deployment requirements if current outbreak continues or expands globally
The joint assay development strategy is expected to more rapidly address the needs of the international community if the current outbreak expands globally, or if localized governmental or non-governmental support is needed in the areas of DRC and
The proposed development program includes evaluation of both BDBV-specific and pan-Ebola assay configurations designed to detect multiple ebolavirus species. The Company is also evaluating workflow configurations intended to support point-of-care and decentralized testing environments for the Co-Dx PCR point-of-care platform*.
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*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.
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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 Bundibugyo virus ("BDBV") with CoSara Diagnostics; (ii) the potential future development, validation, regulatory review, commercialization, manufacture, and distribution of a BDBV test; (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; 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 BDBV 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
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SOURCE Co-Diagnostics
