Ventana Medical Systems has received FDA approval for the application of its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the BenchMark ULTRA automated slide staining platform.
The BenchMark XT instrument, the HER2 Dual ISH assay, is now approved for use on both Ventana BenchMark advanced staining platforms available in the US.
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, the company said.
Ventana Advanced Staining Assays lifecycle leader Greg Yap said the INFORM HER2 Dual ISH assay improves treatment of breast cancer patients by providing clinicians increased accuracy and faster time to result.
