Werfen Gains CE Mark for Aptiva Reagent for Autoimmune Disease Testing

Werfen has received a CE mark for its Aptiva CTD (connective-tissue disease) reagent for use on the Aptiva lab system, an automated, high-throughput system that enables clinical laboratories to process multiple analytes simultaneously from a patient sample.

Aptiva, which will initially test for several autoimmune diseases, has more than 60 analytes in various stages of advanced development, the company said.

San Diego, Calif.-based Inova Diagnostics, a Werfen subsidiary, gained 510(k) clearance from the FDA for the Aptiva system in June.