Ventana Receives FDA Clearance for Progesterone Receptor 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 (FDA) for the VENTANA Companion Algorithm Progesterone Receptor (1E2) image analysis application used with the VENTANA iScan Coreo Au scanner running VIRTUOSO software. This announcement comes on the heels of two other FDA clearances Ventana recently announced for the HER2 (4B5) and Ki-67 (30-9) image analysis and digital read applications. The PR (1E2) image analysis algorithm assists pathologists in the detection and semi-quantitative measurement of PR expression in formalin-fixed, paraffin-embedded normal and neoplastic breast tissue. This application aids the pathologist in achieving consistency and objectivity in PR interpretation for breast cancer patients.