NEW YORK (GenomeWeb) – Co-Diagnostics has announced that its Logix Smart MTB Test for diagnosing tuberculosis has received CE mark.
The test can now be marketed in the EU and other areas that recognize the designation.
The Salt Lake City, Utah-based firm's assay detects DNA of Mycobacterium tuberculosis (MTB) complex members and uses real-time PCR to detect and amplify the IS6110 and MPB64 regions in the MTB genome.
Co-Diagnostics will manufacture the Logix Smart MTB test at the firm's ISO 13485:2016-certified facility in Utah. However, the firm noted that it is not seeking US Food and Drug Administration approval due to the low domestic rate of tuberculosis incidents.
"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," Co-Diagnostics CEO Dwight Egan said in a statement. He noted that the firm's technology is "also being used to design tests for HIV and multi-drug resistant tuberculosis."