HER2 Test Aids Treatment for Breast Cancer

The system has been cleared by the U.S. Food and Drug Administration for use as a complement to the DakoCytomation HercepTest for the detection and measurement of HER2/neu, important for assessing patients for whom trastuzumab (Herceptin) treatment is being considered.

The system, called ACIS, combines proprietary color-based imaging technology with automated, digital microscopy to increase detection sensitivity over existing manual methods. It is the first such device that can count and classify as well as detect the presence of HER2/neu, according to ChromaVision Medical Systems, Inc. (San Jan Capistrano, CA, USA), which developed the system.

"These test results help physicians decide how to manage and treat each individual patient and assist in the prediction of patient outcomes,” said Michael G. Schneider, executive vice president and COO of ChromaVision. "Data in this FDA submission substantiate the ability of our ACIS system to provide superior interpathologist and interlaboratory standardization and accuracy over traditional assessment by manual microscopy.”




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