FDA approves Inform HER2 Dual ISH DNA Probe cocktail assay (Ventana MS) as Breast Cancer assay

The FDA has approved the Inform HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH), from Ventana Medical Systems, for use on the Ventana BenchMark ULTRA automated slide staining platform. It was originally approved by the FDA in June 2011 for use with the BenchMark XT instrument. The Inform 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). The HER2 Dual ISH assay detects both HER2 and chromosome 17 on a single slide using a standard light microscope. Unlike FISH assays, the HER2 Dual ISH assay uses robust brightfield detection technology to deliver a result which may be easily interpreted by a pathologist as it allows them to screen the entire tissue sample for regions of HER2 gene amplification. 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.