ROCKVILLE, Md -- July 8, 2008 -- The US Food and Drug Administration (FDA) has approved a novel genetic test, SPOT-Light, for determining whether patients with breast cancer are good candidates for treatment with trastuzumab (Herceptin).
"When used with other clinical information and laboratory tests, this test can provide healthcare professionals with additional insight on treatment decisions for patients with breast cancer," said Daniel Schultz, MD, FDA Center for Devices and Radiological Health, Rockville, Maryland.
The FDA based its approval of the SPOT-Light test on a study using tumour 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.
SOURCE: US Food and Drug Administration
