Co-Diagnostics Develops Ebola Assay Strategy Following Recent Global Outbreak Alert
Recent pathogens illustrate need for improved situational awareness capabilities, such as those provided by the Co-Dx PCR point-of-care platform
Follows outbreak of Ebola and WHO emergency declaration, and enhanced CDC traveler screening measures
"We are pleased to report that we have completed the assay development strategy for BDBV, and should a situation arise requiring the assay, we expect we would be well positioned to execute the strategy and rapidly make the test available," said
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The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats.
*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 development strategy for Bundibugyo virus ("BDBV"); (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; (v) the potential role of real-time situational awareness and cloud-connected diagnostic systems in public health response efforts; and (vi) 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
