The company’s Ventana HER2 (4B5) assay was earlier labeled only for the identification of HER2-positive breast and gastric cancer patients for whom Herceptin (trastuzumab), a HER2-directed therapy, treatment is being considered.

Herceptin therapy has been in use for more than a decade for people with HER2-positive breast cancer. Recently, Roche has introduced two additional HER2-directed therapies, Perjeta and Kadcyla, to further help build on the progress made with Herceptin.

Roche’s Perjeta is approved for use in combination with Herceptin and docetaxel chemotherapy in patients with HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic disease.

Kadcyla is approved to treat patients with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin and a taxane chemotherapy.

Breast carcinoma HER2 (4B5) positive

Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2+ and has not spread into the lymph nodes.

Ventana Medical Systems companion diagnostics vice president Doug Ward noted the company is a global leader in companion diagnostics.

"Our HER2 diagnostics portfolio, including both the VENTANA IHC and INFORM HER2 Dual ISH assays, is the market leader in terms of automation, medical value and customer adoption.

"We are working to enable the VENTANA HER2 (4B5) IHC companion diagnostic assay in all markets where Perjeta and Kadcyla are available for therapy, bringing this technology to physicians and patients worldwide," Ward added.

Image: Breast carcinoma HER2 (4B5) positive Photo: Courtesy of Ventana Medical Systems, Inc.