Roche's Ventana Receives FDA Approval of INFORM HER2 Dual ISH Assay on the BenchMark ULTRA

Ventana Medical Systems, Inc., a member of the Roche Group RHHBY, announced today that the FDA has approved the application of its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the VENTANA BenchMark ULTRA automated slide staining platform for commercialization in the United States. Originally approved by the FDA in June 2011 for use with the BenchMark XT instrument, the HER2 Dual ISH assay is now approved for use on both VENTANA BenchMark advanced staining platforms available in the U.S. The HER2 Dual ISH assay is intended for use in the determination of HER2 gene status in breast cancer tissue as an aid in the assessment of patients that may be considered for treatment with Herceptin (trastuzumab). Herceptin is clinically proven to improve outcomes for patients with HER2-positive breast cancer.