NEW YORK ─ MedMira said Thursday it has obtained the CE mark for its Multiplo Complete Syphilis (TP/nTP) Antibody Test, enabling its use in the European Union and other geographies that accept the designation.
Nova Scotia, Canada-based MedMira said the test is available for both screening and confirmation of syphilis and takes less than three minutes from sample collection to result. It detects treponemal and non-treponemal antibodies, targeting biomarkers of active and previous infections, enabling a complete diagnosis of syphilis using one device, the firm said.
The test is designed for users who do not have ready access to a venereal disease research laboratory test or a rapid plasma reagin test, such as doctors' offices, pharmacies, and home test users, MedMira CEO Hermes Chan said in a statement.
In March, MedMira announced it had obtained the CE mark for its Reveal TP (Syphilis) test to diagnose acute syphilis infections. The product is designed for hospitals and healthcare providers that provide screening and could use the Reveal antibody test for confirmation.