FDA Approves use of Breast Cancer Assay on BenchMark ULTRA

Ventana Medical Systems, Inc., has announced FDA approval of its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2Dual ISH) for use on the VENTANA BenchMark ULTRA automated slide staining platform. The assay was originally approved by the FDA in June 2011 for use with the BenchMark XT instrument.

The HER2 Dual ISH assay is intended to determine HER2 gene status in breast cancer tissue of patients being considered for Herceptin (trastuzumab) treatment. Herceptin in clinically proven to improve outcomes for patients with HER2-positive breast cancer. The assay detects HER2 and chromosome 17 on a single slide using a standard light microscope.

“The INFORM HER2 Dual ISH assay improves treatment of breast cancer patients by providing clinicians increased accuracy and faster time to result compared to fluorescent in situ hybridization (FISH) assays,” said Greg Yap, Lifecycle Leader, Advanced Staining Assays at Ventana. “In a Ventana clinical study comparing HER2 Dual ISH to FISH, our findings showed that more patients would have received the correct result and be identified as potential candidates for Herceptin therapy using our ISH test. In addition, FISH assays for gene amplification must be run manually by skilled technologists, making them labor-intensive and time consuming. The average turn-around time for HER2 FISH testing in breast tissue is 2-3 days as opposed to approximately 13 hours for HER2 Dual ISH testing. We are pleased to offer all of our customers and patients worldwide our HER2 Dual ISH assay with its benefits over traditional FISH testing.”

The HER2 Dual ISH assay combined with the PATHWAY HER2 (4B5) immunohistochemistry assay provides clinicians with highly accurate tools for determining the HER2 status of a patient. This enables clinician and patient to move forward with a targeted treatment plan.