New VENTANA HER2 ISH DNA Assay Launches for Breast, Gastric Cancers

Michael Heuer

A new VENTANA HER2 dual in situ hybridization (ISH) companion diagnostic assay has launched to identify HER2 amplification for patients with breast cancer and gastric cancer who could be eligible to receive trastuzumab (Herceptin), according to Roche, the manufacturer of the test.

The assay, which is called the VENTANA HER2 Dual ISH DNA Probe Cocktail assay, is currently available in Europe, the Middle East, Africa, Latin America, and Asia Pacific. An application for the test will be submitted to the FDA for approval, the company stated in a press release.

“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,” Michael Heuer, CEO, Roche Diagnostics, said in the press release. “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.”

The brightfield assay is designed to identify patients who have HER2-positive breast or gastric cancer and would be candidates to receive trastuzumab, which is also manufactured by Roche. Additionally, the test is devised to be completed within the same day, which Roche stated is quicker than most HER2 confirmatory tests. Additionally, the assay is fully automated on BenchMark immunohistochemistry/ISH instruments.

Results from VENTANA HER2 Dual ISH DNA Probe Cocktail assay can be read via microscopy, which eliminates the need for a specialized fluorescence microscope.

Approximately 15% to 20% of patients who are diagnosed with breast cancer have HER2-positive disease. Other HER2 assays that Roche develops include the VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, INFORM HER2 Dual ISH DNA Probe Cocktail assay, and the PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody.

Trastuzumab is approved by the FDA for the adjuvant intravenous (IV) treatment of patients with HER2-overexpressing, node-positive or node-negative breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; and as a single agent following multimodality anthracycline-based therapy. It is also indicated as a single agent for patients with HER2-overexpressing breast cancer who have received one or more chemotherapy regimens for metastatic disease, or in combination with paclitaxel as a first-line treatment for patients with HER2-overexpressing metastatic breast cancer.

The agent is also indicated in combination with cisplatin/capecitabine or 5-fluorouracil for the first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

In February 2019, the FDA approved subcutaneous use of trastuzumab and hyaluronidase-oysk injection (Herceptin Hylecta) in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic HER2-positive breast cancer as a frontline treatment, and alone for patients with metastatic disease who have received at least 1 prior chemotherapy regimen.

The approval was based on data from the HannaH (NCT00950300) and SafeHER (NCT01566721) studies, in which Herceptin Hylecta demonstrated comparable rates of efficacy and safety compared with the standard IV use of trastuzumab, as well as the PrefHER trial (NCT01401166), which suggested a patient preference for the subcutaneous regimen.

Roche Launches New VENTANA HER2 Dual ISH Companion Diagnostic Test For Breast and Gastric Cancer Patients Eligible for Targeted Therapy. Roche. Published April 23, 2019. https://bit.ly/2XDMfZY. Accessed April 23, 2019.