Company’s multiplexed Logix Smart™ ZDC Test to be available for purchase with CE mark in March 2019
Salt Lake City, Utah – February 26, 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 (multiplex Zika-dengue-chikungunya) Test technical file has been submitted for registration with the European Community, and that the in vitro diagnostic (“IVD”) is expected to be available for purchase in March 2019 in markets that accept a CE mark as valid regulatory approval.
Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, “We are pleased to announce the launch of the Company’s first multi-disease diagnostic, built using our patented CoPrimer™ design platform. The unique properties of CoPrimer molecules not only lead to a massive reduction in “primer-dimers,” the often-occurring phenomenon that creates false positives in these types of diagnostics, but they are also ideally suited for multiplexing, or identifying multiple targets at once. Our multiplex test for Zika, dengue, and chikungunya was developed in direct response to market demand for an affordable, highly-specific diagnostic tool for all three diseases.”
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 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.
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.
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