Co-Diagnostics Completes Submission of CE Mark Registration for Zika/Dengue/Chikungunya Multiplex Test
Company’s multiplexed Logix Smart™ ZDC Test to be available for
purchase with CE mark in
Co-Diagnostics’ Logix Smart ZDC Test functions via real-time reverse transcriptase polymerase chain reaction (RT-PCR) to differentiate between the RNA of Zika, dengue (all 4 serotypes), and chikungunya viruses and to detect and amplify regions of the viruses’ genomes. The three viruses are spread by the same Aedes mosquitos and have similar symptoms, including sever fever and joint pain, which has historically led to false diagnoses. However, therapeutics differ for the three diseases, and physicians require accurate diagnostic tools that can detect and distinguish between the viruses in order to determine the most appropriate treatment.
Mr. Egan continued, “Enhanced specificity—or discriminating between similar genetic sequences to avoid false positive diagnoses—is one of the most valuable characteristics of the CoPrimer technology, especially in multiplexed assays. Our ZDC multiplex test provides patients and health care providers a low-cost solution to test for all three viruses at once, with the confidence that the test results will aid in determining the most suitable treatment for each patient. Early and accurate detection of severe dengue, for example, can lower the mortality rate to below 1% from as high as 50% when left untreated or treated improperly. With over 50% of the world’s population living in zones at risk for infection, and increased reported infections rates on the rise for all three diseases, we anticipate a robust market for this high-demand product.”
The technical file dossier submitted to the Company’s authorized
European representative includes a description of the test to support
conformance to the CE marking standards, which will confirm that the
test meets the Essential Requirements of the European Community’s
In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC). The
registration process is expected to be complete by early March, at which
point sales of the product may commence as an IVD with the CE marking
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions.Forward-looking statements in this release include statements regarding the (i) use of funding proceeds, (ii) expansion of product distribution, (iii) acceleration of initiatives in liquid biopsy and SNP detection, (iv) use of the Company’s liquid biopsy tests by laboratories, (v) capital resources and runway needed to advance the Company’s products and markets, (vi) increased sales in the near-term, (vii) flexibility in managing the Company’s balance sheet, (viii) anticipation of business expansion, and (ix) benefits in research and worldwide accessibility of the CoPrimer technology and its cost-saving and scientific advantages. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances.Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
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