Novel genetic test for breast cancer

August 13, 2008

The SPOT-Light HER2 CISH kit a genetic test that measures the number of copies of the HER2 gene in breast tumor tissue received approval recently from the Food and Drug Administration.

The SPOT-Light HER2 CISH kit‑a genetic test that measures the number of copies of the HER2 gene in breast tumor tissue‑received approval recently from the Food and Drug Administration for the identification of patients who might benefit from treatment with the drug trastuzumab (Herceptin).

The FDA’s approval is based on studies in the United States and Finland, which supported the accuracy of SPOT-Light, manufactured by Invitrogen Corp. of Carlsbad, CA.

During the test, a small sample of tumor tissue is stained with a chemical that causes color changes in HER2 genes. Unlike existing tests, which require fluorescent microscopes, SPOT-Light reveals changes that can be observed with a standard microscope. In addition, the test allows labs to store the tissue for future reference.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

FDA News Release: FDA Approves New Genetic Test for Patients with Breast Cancer. Available at:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01857.html

. Accessed August 7, 2008.