FDA Clears Roche’s Fully Automated Her2 Gene Status Diagnostic Assay

Test developed by Ventana subsidiary is carried out on an automated slide preparation system and detects both Her2 and chromosome 17.

FDA has approved Ventana Medical Systems’ Inform Her2 Dual ISH DNA Probe cocktail assay.  Ventana is owned by Roche. The firm claims the test is the first fully automated assay to obtain FDA clearance for determining Her2 gene status in breast cancer and for use as an aid to assessing patients’ suitability for treatment with Herceptin. The product was granted CE-IVD clearance in Europe in 2010.

The Inform Her2 Dual ISH assay detects both Her2 and chromosome 17 on a single slide using a standard light microscope. The brightfield detection technology is carried out on the Ventana BenchMark XT fully automated slide-preparation system, generating results that can be shared and stored.

“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, comments Eric Walk, M.D., Ventana’s CEO. “We believe this adds significant medical value for the patient and is an important advance toward improved patient-focused solutions.

The Benchmark XT platform comprises a staining module that enables optimized, automated preparation and processing of IHC, ISH, and immunofluorescence slide applications, Ventana claims.  The automated fluidics module houses bulk solutions specifically formulated for automated applications, with an on-board bulk fluid capacity sufficient to process up to 90 slides.

The slide technology includes a precisely controlled reaction environment  based on air vortex mixers, liquid coverslip, heater pad, and E-Bar barcode slide label system.  The air-vortex mixers effectively blend the aqueous layer under the liquid coverslip, mixing reagents and ensuring uniform reaction kinetics across the entire surface of the slide.

The liquid coverslip creates a reaction chamber on the surface of each slide, controlling evaporation and protecting tissue integrity. Individual slide heater pads provide precise heating across the entire surface of each slide, and the E-Bar barcode slide label system generates a slide-specific label enabling automatic programming, patient and case identification.