Ventana Medical Systems, a member of the Roche Group, has received the US Food And Drug Administration (FDA) approval for its INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) to improve outcomes for patients with HER2-positive breast cancer.
The HER2 Dual ISH assay detects both HER2 and chromosome 17 on a single slide using a standard light microscope.
The Ventana HER2 Dual ISH assay transforms the diagnostic process by providing complete, automation on the VENTANA BenchMark XT instrument and reduces the turnaround time for results.
Ventana CMO Eric Walk said unlike FISH assays, this detection technology delivers a result which is interpreted and produces signals that don’t fade over time and allows results to be stored and shared between pathologists.
"By having both signals visible on a single slide using light microscopy, we can determine the HER2 gene status within the morphological context of the tumor," Walk said.