NEW YORK ─ Canadian firm MedMira said Wednesday it has obtained the CE mark for its Reveal TP (Syphilis) test, making it available in the European Union as well as other geographies that accept the designation.
The syphilis rapid test detects Treponema pallidum antibodies in serum, plasma, or whole blood, according to MedMira's website. The CE marking enables testing in point-of-care settings, broadening access for end users, Hermes Chan, CEO of MedMira, said in a statement.
The Nova Scotia-based firm added that it is also working on an investigational testing application for a planned clinical trial in Canada that would enable the collection of performance data for the syphilis test.
The clinical trial is expected to start in the spring in collaboration with Reach Nexus, a research group at St. Michael's Hospital of Unity Health Toronto.
MedMira said Reach Nexus is using funding from the Canadian Institutes of Health Research to address disease epidemics by working with Canadian in vitro diagnostic developers, healthcare providers, community stakeholders, and others.