Roche has introduced new Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in breast and gastric cancer patients.


Image: The administration and R&D buildings, Roche Diagnostics, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.

Human epidermal growth factor receptor 2 (HER2) is a significant biomarker observed in breast and gastric cancers.

Ventana HER2 Dual ISH DNA Probe Cocktail assay can be completed within the same day, offering clinicians with quicker results compared to the most common methods of confirmatory testing for HER2.

Results can be read using light microscopy, helping to avoid the use of a specialized fluorescence microscope.

Roch claims that it is the only provider of a fully automated brightfield Dual ISH solution to detect HER2 amplification.

The new Ventana HER2 Dual ISH DNA Probe Cocktail assay can be fully automated on the BenchMark IHC/ISH instruments. It quickly offers clear results to pathology labs, enabling to make treatment decisions earlier.

At present, the assay is available in Europe, the Middle East and Africa, as well as Latin America and Asia Pacific. The company is also planning to submit an application with the US Food and Drug Administration for approval.

Herceptin is a humanized monoclonal antibody, which will target and inhibit the function of the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers.

Herceptin binds to a specific section of the HER2 protein, restricting the signals it sends that advance tumor cell growth and also alerts body’s immune system to attack the cancer cells.

Roche offers a comprehensive menu of both diagnostic and predictive assays, including the Ventana HER2/neu (4B5) rabbit monoclonal primary antibody that will help assess breast cancer patients for whom Herceptin treatment is considered.

Roche Diagnostics CEO Michael Heuer said: “The new VENTANA HER2 Dual ISH assay advances Roche’s commitment to personalized healthcare by delivering critical information on treatment options for breast and gastric cancer patients faster.

“Quick results are crucial in the fight against cancer, and every additional day that a clinician and a patient must wait for test results is a day too long.”