Ventana HER2 Dual ISH Assay, A New Diagnostic Tool From Roche, Offers One-Day Breast Cancer Diagnosis

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When your doctor suspects that you have breast cancer but the official results are hung up in the lab, the uncertainty can be agonizing.

Now there’s a new tool that can give patients a cancer diagnosis the same day.

Developed by Roche, the VENTANA HER2 Dual ISH assay can diagnosis whether or not breast and gastric cancers have HER2 genetic mutations.

HER2 stands for human epidermal growth factor receptor 2, and it’s a protein found in both breast and gastric cancers. About 15% to 20% of breast cancer cases are HER2-positive, and it is a very aggressive form of the disease.

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The presence of HER2 impacts breast cancer treatment significantly. Experts recommend that every invasive breast cancer be tested for the protein, and tested again if the breast cancer recurs or spreads from the original site.

VENTANA can identify the HER2 biomarker more quickly than the most common current methods of testing; it’s designed to give results within one day.

Because results from this assay can be read using with light microscopy — a common microscope — it allows for speedier results and eliminates the need for a more expensive, specialized fluorescence microscope.

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Roche is a global pioneer in pharmaceuticals and diagnostics. The addition of this diagnostic tool is the next step in Roche’s plan to provide personalized treatment strategies to patients who need specific medicines. They’re responsible for the development of the groundbreaking drug Herceptin (generic name trastuzumab), which has been instrumental in treating HER2-positive patients and is now a standard part of care.

According to the Roche website, “in situ hybridization (ISH) analysis provides important information related to tumor biology, helps profile types of breast cancer and may improve treatment decisions.”

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“The new Ventana HER2 Dual ISH assay advances Roche’s commitment to personalised healthcare by delivering critical information on treatment options for breast and gastric cancer patients faster,” Roche Diagnostics CEO Michael Heuer said. “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.”

At the time of this writing, this diagnostic tool is available in Europe, the Middle East, Africa, Latin America and Asia Pacific. It’s being submitted to the U.S. Food and Drug Administration (FDA) for approval.

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C. Dixon likes to read, sing, eat, drink, write, and other verbs. She enjoys cavorting around the country to visit loved ones and experience new places, but especially likes to be at home with her husband, son, and dog.
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