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BDA International Release: Co-Diagnostics Inc.: CE markers and anticipated Future Growth

BARCELONA, CATALUNYA, SPAIN, July 25, 2018 /EINPresswire.com/ --
Co-Diagnostics, Inc. (“CODX”) is a molecular diagnostics company that has developed a unique, patented and patent-pending diagnostic testing technology. A Utah corporation headquartered in Salt Lake City, Utah, its primary business is to commercialize its technology through sales, development and licensing. The innovative technology is embodied in 5 patents granted and pending and certain trade secrets, which make DNA testing for diseases faster, higher in performance, and more cost efficient than traditional technologies of the past. In addition to infectious disease testing, it also has broad applications for liquid biopsy, next-gen sequencing, and SNP detection.

Today the Company announced today that its Logix Smart™ MTB Test technical file has been approved for registration with the European Community, and that the CE marked in vitro diagnostic (“IVD”) is expected to be available for purchase early in August in markets that accept a CE mark as valid regulatory approval.

The Logix Smart MTB Test detects DNA of mycobacteria tuberculosis (MTB) complex members and functions via real-time polymerase chain reaction (PCR) to detect and amplify the regions of the MTB genome.

The key component to battling tuberculosis is an early, accurate, and affordable diagnosis. The Company expects that this will help them to better meet the global demand for detection of a disease that causes over 1.5 million deaths per year. Roughly 95% of these deaths occur in low and middle-income countries, which includes those in Eastern Europe in addition to many across Central America and the Caribbean basin. In the case of the latter, the Departments or Ministries of Health recognize clearance by the European Community as valid regulatory approval to allow sale of CE marked products throughout their jurisdictions.

With the number of infections upwards of 10.5 million per year, and 99.9% of those occurring outside the United States, the Company believes that a CE marking is the most appropriate and effective route to address this growing market in need of a competitively-priced diagnostics solution, which they also anticipate will have a positive impact on their financial growth in the future.

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Forward-Looking Statements:

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