Roche Group's Ventana Medical Systems has announced the Ventana HER2/neu (4B5) rabbit monoclonal primary antibody assay as a companion diagnostic for detecting HER2 protein expression for patients who may be appropriate candidates for Perjeta and Kadcyla.
The Ventana HER2 (4B5) test was previously labelled only for the indication of HER2-positive breast and gastric cancer patients for whom Herceptin (trastuzumab) treatment is being considered. However, it is now labelled for the indication of Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine) in countries where these drugs are approved.
Perjeta is cleared for use in combination with Herceptin and docetaxel chemotherapy in patients with HER2-positive metastatic breast cancer (mBC) and who have not received anti-HER2 therapy or chemotherapy for metastatic disease.
Kadcyla is approved for the treatment of HER2-positive mBC in patients who have received prior treatment with Herceptin and a taxane chemotherapy.
Patients 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.
Ventana president Mara G Aspinall said in line with company's mission to improve the lives of all patients afflicted with cancer, its HER2 assay will continue to provide important diagnostic information for breast cancer treatment decisions.
"We are proud to be the preferred tissue diagnostics partner for our Roche Pharma colleagues," Aspinall said. "This announcement also signifies the unique ability of Roche to deliver healthcare to cancer patients worldwide."
According to the National Cancer Institute, breast cancer is the most common cancer in women worldwide and the second leading cause of death from cancer among women globally.
Approximately one-fifth of breast cancers are classified as HER2- positive and when left untreated, HER2-positive breast cancer patients typically have 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 companion diagnostics vice-president Doug Ward said: "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 is currently engaged in more than 150 collaborative projects to develop and commercialise companion diagnostics globally.
Image: Breast carcinoma HER2 (4B5) positive, Score: 3 Magnification: 40X. Photo: courtesy of Ventana Medical Systems.