26 February 2019 - - US-based molecular diagnostics company Co-Diagnostics, Inc.'s (NASDAQ: CODX) Logix Smart ZDC (multiplex Zika-dengue-chikungunya) Test technical file has been submitted for registration with the European Community, and the in vitro diagnostic is expected to be available for purchase in March 2019 in markets that accept a CE mark as valid regulatory approval, the company said.

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.

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 included.

Co-Diagnostics will manufacture its Logix Smart ZDC Test in the company's ISO 13485:2016 facility for development and manufacture of IVD Medical Devices located in Utah, USA.

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.