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Early Adopter of INFORM HER2 Dual ISH Assay Optimistic About Impact on Patient Care, Hospital Bottom Line
Date:9/12/2011

assays to test for HER2 gene amplification. These assays must be run manually by skilled technologists, making them extremely labor-intensive and time consuming.

HER2 Dual ISH Technology; 'Adds Significant Medical Value for The Patient'

Breast cancer is the second leading cause of cancer-related death among women. An estimated 207,090 new cases of breast cancer were diagnosed in the United States during 2010 and close to 39,800 women died from the disease, according to the National Cancer Institute. About 20 percent of women diagnosed with breast cancer are HER2-positive.

The HER2 Dual ISH assay measures the number of copies of the HER2 gene in tumor tissue. Defining a patient's HER2 status allows the treatment team to predict response to Herceptin therapy, which has been clinically proven to improve outcomes for patients with HER2-positive breast cancer.

With the HER2 Dual ISH assay, the HER2 gene status is determined on a single slide using a standard light microscope. Unlike FISH assays, the HER2 Dual ISH assay uses robust brightfield detection technology to deliver results that are easily interpreted, and the signals do not fade over time.  This allows the actual slides to be stored long term and easily shared between pathologists and oncologists.

"This new technology will impact our practice in many positive ways -- one of the most important is the ability to archive the slides," says Dr. Lauren LeBeau, UMC breast cancer specialist and assistant professor of pathology. "Using the HER2 Dual ISH assay, we can easily show the slides and share with the treatment team how and why we interpreted slides the way we did. We work with the oncologists to make critical diagnostic decisions, and being able to view all the information possible will lead to a greater continuity of patient care."

The FDA approval of HER2 Dual ISH in June of 2011 was based on a U.S. study involving tumor samples from 510 patients with breas
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SOURCE Ventana Medical Systems, Inc.
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