The U.S. Food and Drug Administration (FDA) has approved a new way to figure out if a breast cancer is HER2-positive. The test is called SPoT-Light HER2 CISH and uses a stain that makes HER2/neu genes change color. The stain is applied to a breast cancer tissue sample and looked at with a microscope. The SPoT-Light HER2 CISH test is less complicated than the FISH (fluorescence in situ hybridization) test or the IHC (ImmunoHistoChemistry) test that are used today.
HER2-positive cancers have extra HER2 genes and make too many HER2 protein receptors. About 1 out of every 4 breast cancers is HER2-positive. HER2-positive breast cancers tend to be more aggressive than HER2-negative breast cancers.
Herceptin (chemical name: trastuzumab) and Tykerb (chemical name: lapatinib) are targeted therapies used to treat HER2-positive breast cancers. Herceptin is approved to treat women with both early-stage and advanced-stage HER2-positive breast cancer. Tykerb is approved to be given in combination with Xeloda (chemical name: capecitabine) to treat advanced, HER2-positive breast cancer that has stopped responding to anthracyclines, taxanes, and Herceptin.
Visit the Breastcancer.org Targeted Therapies section to learn more about HER2-positive breast cancer, Herceptin, and Tykerb.
ROCKVILLE, Md., July 8 (MedPage Today) -- The FDA has approved a genetic test that can be used to identify breast cancer patients whose tumors are HER2-positive, making them candidates for treatment with trastuzumab (Herceptin).
The test, SPOT-Light HER2 CISH, measures copies of HER2 genes in a small sample of removed tumor.
The biopsied tissue is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more complex fluorescence in situ hybridization (FISH) required to read assays already on the market.
Moreover, the SPOT-Light test can be used to assess HER2 expression in stored tissue. The FDA said current tests are not effective with frozen specimens.
Patients whose tumors over-produce HER2 protein are typically treated with the drug trastuzumab, which targets HER2 protein production.
Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health said the new test can be used in combination with clinical information and other laboratory tests to inform treatment decisions.
The FDA approval was on the basis of a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.
SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Trastuzumab is manufactured by Genentech.
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