Logix Smart™ ZDC Test now available for export from the United States as a CE-marked IVD
Salt Lake City, Utah – March 7, 2019 – Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ ZDC Test has obtained CE mark regulatory clearance to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of Zika, dengue, and chikungunya in accepting markets, and is now available for purchase from the Company’s Utah-based ISO-13485 facility.
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 across the Caribbean basin and Latin America in which the Company already has distribution agreements in place. Co-Diagnostics expects regulatory approval for such a high-demand test to facilitate the creation of additional sales and distribution opportunities in those areas.
Dwight Egan, Chief Executive Officer of Co-Diagnostics, commented, “Receiving the CE mark for our CoPrimer™-based multiplex ZDC assay is the capstone of the design, development, validation, and regulatory approval process, which was completed from start to finish in under 6 months. This highly-specific diagnostic for three harmful diseases at once is possible due to our patented CoPrimer design platform enabling a massive reduction in false positives, which is especially important—but notoriously more difficult—in multiplexed assays of related pathogens. The exceptional performance of the Logix Smart ZDC test and our efficient development process are both further validations of our technology, and of the quality of our dedicated personnel.
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 https://codiagnostics.com/products/diagnostic-solutions/logix-smart-zdc/ or via the Company contact at the bottom of this release.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is 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 to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.
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, (ix) benefits in research and worldwide accessibility of the CoPrimer™ technology and its cost-saving and scientific advantages and (x) statements regarding the intended use of proceeds. 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.
Company Sales Contact:
Head of International Sales
+1 801-438-1036 #2