WASHINGTON, July 8 The U.S. Food and Drug Administration said on Tuesday it approved Invitrogen Corp's IVGN.O genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin.
Invitrogen's SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. Patients who overproduce the HER2 protein are typically treated with the drug Herceptin, which is made by Genentech Inc DNA.N.
"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," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement. (Reporting by Julie Vorman, editing by Gerald E. McCormick)