Ventana Receives FDA Clearance for HER2 (4B5) Image Analysis and Digital Read Applications

Ventana Medical Systems, Inc., a member of the Roche Group

, received 510(k) clearance from the U.S. Food and Drug Administration for the VENTANA Companion Algorithm HER2 (4B5) for image analysis applications with associated VIRTUOSO software and iScan Coreo Au scanner. Ventana is now the only company with a complete workflow solution for determining HER2 (4B5) expression in breast cancer patients. The application assists the pathologist in the detection and semi-quantitative measurement of HER2 (4B5) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. While the pathologist is still the ultimate authority in scoring HER2 (4B5) stains, the image analysis application helps ensure consistency and objectivity in interpretation.