SALT LAKE CITY—Co-Diagnostics, Inc., a molecular diagnostics company, has announced 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. It 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 Co-Diagnostics 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.
“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,” said Dwight Egan, chief executive officer of Co-Diagnostics.
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.
“Over 50% of the world’s population live in zones at risk for infection of one or more of Zika, dengue, or chikungunya,” noted Egan. “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.”