Ventana Announces HER2 Companion Diagnostic to Identify Breast Cancer Patients for Roche's Latest Targeted Medicines
17 Dec 2013

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, has announced the VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay as a companion diagnostic1 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 labeled 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 women2 and the second leading cause of female cancer-related deaths3. Approximately one-fifth of breast cancers are classified as HER2- positive and if left untreated are associated with poorer clinical outcomes4. 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 can be used in several different ways:

• As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC®TH"
• With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH"
• Alone after treatment with multiple other therapies, including an anthracycline-based therapy (a type of chemotherapy)
*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age

Herceptin has two approved uses in metastatic breast cancer:

• Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
• Herceptin alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

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.

For full details of important safety information regarding Perjeta and Kadcyla, please follow the company website link below to see the full original press release.




1The VENTANA HER2 (4B5) IHC assay is a CE-IVD companion diagnostic available outside the U.S. Check with your local representative for availability in your area. VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is not available or approved for use in the United States.

2World Health Organization

3National Cancer Institute

4Sullivan and Swain. Expert Opin. Biol. Ther. 2013. 13(5):779-90

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Sonia Nicholas
Clinical Diagnostics Editor