Roche, Basel, Switzerland, has announced the international launch of its Ventana HER2 dual ISH DNA probe cocktail assay for detection of the human epidermal growth factor receptor 2 (HER2) biomarker in breast and gastric cancer. The assay provides clear results to pathology labs more quickly, enabling clinicians to make treatment decisions earlier.

HER2 is an important biomarker found in breast and gastric cancers.1 Its detection and inhibition can help to more effectively manage these aggressive types of cancer. Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.2 About 15% to 20% of women diagnosed with breast cancer are HER2 positive.3

The Ventana HER2 dual ISH DNA probe cocktail assay is designed to be completed within a single day, allowing clinicians to get results more quickly than the most common methods of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope. The test provides an improved brightfield assay that is fully automated on the company’s BenchMark IHC/ISH instruments.


Michael Heuer, Roche Diagnostics.

The Ventana HER2 dual ISH DNA probe cocktail assay aids in identifying breast and gastric cancer patients eligible for the targeted Roche drug Herceptin (trastuzumab). Herceptin is a humanized monoclonal antibody designed to target and block the function of the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive (HER2+) cancers. Herceptin binds to a specific section of the HER2 protein, inhibiting the signals it sends that encourage tumor cell growth, while also calling on the body’s immune system to attack the cancer cells.

Since it was first approved, in 1998, Herceptin has been used worldwide to treat more than two million patients diagnosed with HER2+ breast and gastric cancers. It has also become the backbone of other innovative treatments for HER2+ breast cancer, which have continued to improve the outcomes of patients with this otherwise aggressive disease. The subcutaneous formulation of Herceptin, approved in 2013, represents a significant step in the treatment of HER2+ breast cancer, as it offers patients a faster, more convenient, and less painful way to receive treatment with Herceptin.

“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,” notes Michael Heuer, CEO of Roche Diagnostics. “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 assay is currently being launched in Africa, Asia Pacific, Europe, Latin America, and the Middle East. It will be submitted to FDA for US market authorization.

For further information, visit Roche Diagnostics.


  1. Hofmann M, Stoss O, Shi D, et al. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology. 2008;52(7):797?805; doi: 10.1111/j.1365-2559.2008.03028.x.
  1. Breast [fact sheet, online]. Geneva: International Agency for Research on Cancer, World Health Organization, 2019. Available at: Accessed June 8, 2019.
  2. Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997–4013; doi: 10.1200/jco.2013.50.9984.