Ventana Medical Systems, Inc. (VMSI), a member of the Roche Group, has reported that the Ventana HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic for detecting HER2 protein expression for patients who, in countries where they are approved, may be appropriate candidates for Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).

Previously, the Ventana  HER2 (4B5) test was labelled only for the identification of HER2-positive breast and gastric cancer patients for whom Herceptin (trastuzumab) treatment is being considered.

"In line with our mission to improve the lives of all patients afflicted with cancer, our HER2 assay will continue to provide important diagnostic information for breast cancer treatment decisions," says Mara G Aspinall, president, Ventana Medical Systems, Inc. "We are proud to be the preferred tissue diagnostics partner for our Roche Pharma colleagues.  This announcement also signifies the unique ability of Roche to deliver healthcare to cancer patients worldwide.”

Breast cancer is the most common cancer worldwide for women and the second leading cause of female cancer-related deaths.  Approximately one-fifth of breast cancers are classified as HER2- positive and if left untreated are associated with poorer clinical outcomes.  Defining HER2 status allows the treatment team to better identify which patients may be appropriate candidates for a treatment regimen with a HER2 targeted medicine.

"Ventana 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,” says Doug Ward, vice president, Companion Diagnostics, Ventana Medical Systems, Inc. “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."

In addition to Roche, Ventana has worked with more than 45 bio-pharmaceutical partners over the past decade and is currently engaged in over 150 collaborative projects to develop and commercialize companion diagnostics globally.

For more than a decade, Herceptin (trastuzumab), a HER2-directed therapy, has been approved by health authorities for people with HER2-positive breast cancer. To further help build on the progress made with Herceptin, Roche has recently introduced two additional HER2-directed therapies, Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine).

Perjeta (pertuzumab) is approved for use in combination with Herceptin (trastuzumab) and docetaxel chemotherapy in people 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 (ado-trastuzumab emtansine) is approved for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. People should either have already been treated for their metastatic cancer or have had their early-stage cancer come back during or within six months after they completed a course of treatment following surgery.

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.  If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high risk feature.

Herceptin is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease.

Ventana Medical Systems, Inc., a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics.