Co-Diagnostics, Inc. Receives CE Mark for Zika/Dengue/Chikungunya Multiplex Test
Logix Smart™ ZDC Test now available for export from
The Declaration of Conformity for the Logix Smart ZDC test confirms that
it meets the Essential Requirements of the European Community’s In-Vitro
Diagnostic Medical Device Directive (IVDD 98/79/EC), allowing export and
sales of the product to commence immediately to markets that accept a CE
mark as valid IVD regulatory approval, pending any local product
registration requirements. These markets include several countries
Over 50% of the world’s population live in zones at risk for infection of one or more of Zika, dengue, or chikungunya. With increased reported infections rates on the rise for all three diseases, we believe that this test will have an important and valuable role to play in delivering an affordable diagnostic solution for early, accurate detection to our cost-conscious target market.”
Co-Diagnostics’ Logix Smart ZDC Test functions via a single-step reverse transcriptase real-time polymerase chain reaction to identify and differentiate between the viral RNA of Zika, dengue (all 4 serotypes), and chikungunya. 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. More information related to performance, distribution, or purchasing can be found at http://codiagnostics.com/products/diagnostic-solutions/logix-smart-zdc/ or via the Company contact at the bottom of this release.
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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