Molecular diagnostics company Co-Diagnostics Inc (Nasdaq: CODX) disclosed on Wednesday that its Logix Smart MTB Test has received CE mark approval, which confirms that the test meets the Essential Requirements of the European Community's In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC).

This principle regulatory clearance allows Logix Smart MTB Test to be sold as an in vitro diagnostic (IVD) for the diagnosis of tuberculosis in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.

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 IS6110 and MPB64 regions of the MTB genome.

The company said that it will manufacture the test in its ISO 13485:2016 facility for the development and manufacture of IVD Medical Devices located in Utah, USA. It added that it is not currently seeking approval by the FDA for sale in the US due to the low domestic rate of tuberculosis incidents.

Dwight Egan, chief executive officer of Co-Diagnostics, commented: "This granting of this CE mark represents a milestone not only for Co-Diagnostics, but for all individuals in need of an affordable, high-quality TB diagnostic in areas not blessed with wealth or access to philanthropic subsidies. Our proprietary design platform and CoPrimer technology, on which this test was built, are now also being used to design tests for HIV and multi-drug resistant tuberculosis ("MDR-TB"). These diagnostics are in high demand where TB is prevalent and will further augment the tools available to people in those areas, in addition to expanding the Company's footprint there as well."