FDAnews
www.fdanews.com/articles/108337-fda-approves-new-genetic-test-for-patients-with-breast-cancer

FDA Approves New Genetic Test for Patients With Breast Cancer

July 8, 2008

The FDA has approved Invitrogen’s SPOT-Light HER2 CISH kit as a genetic test for patients with breast cancer.

The HER2 gene regulates the growth of cancer cells. The test measures the number of copied HER2 genes in a tumor tissue.

When used with other tests and clinical information, the FDA said the SPOT-Light test provides additional insight on treatment decisions for patients with breast cancer.