March 8, 2009

FDA Approves New Test to Detect HER2 Status in Breast Cancer


FDA Approves New Test to Detect HER2 Status in Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved a new laboratory test to help identify patients with breast cancer who may benefit from treatment with Herceptin® (trastuzumab).

The human epidermal growth factor receptor 2 (HER2) is part of a biological pathway involved in growth and spread of cancer cells. Several types of cancers overexpress HER2, including approximately 25–30% of breast cancers. These cancers are referred to as HER2-positive. Overexpression of HER2 often results in uncontrolled growth and spread of cancer cells. All breast cancer patients should now be tested for HER2 status before beginning treatment.

Herceptin is targeted against HER2 and helps to slow or stop the spread of cancer cells that overexpress HER2. Herceptin is often used in combination with chemotherapy for the treatment of breast cancer that overexpresses HER2.

In order to determine if patients will benefit from Herceptin, samples of breast cancer tissue are tested in a laboratory. It has been demonstrated, however, that different laboratory testing methods provide different results regarding response to targeted therapy against HER2.

The FDA has approved the SPOT-Light HER2 CISH test to measure gene copies of the HER2 gene. Tissue from breast cancer sample is treated with a chemical that turns the gene copies a different color, which can be visualized under a microscope. The new test is also able to utilize frozen tissue specimens.

Patients diagnosed with breast cancer may wish to speak with their physician regarding their individual risks and benefits of the SPOT-Light HER2 CISH test.

Reference: United States Food and Drug Administration. FDA Approves New Genetic Test for Patients with Breast Cancer. Available at: Accessed July 2008.

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