FDA OK's Invitrogen genetic test for breast cancer

Tue Jul 8, 2008 8:56am EDT

 WASHINGTON, July 8 (Reuters) - 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)