Diagnostic Testing & Technology Report

The U.S. Food and Drug Administration has granted Invitrogen (Carlsbad, Calif.) premarket approval (PMA) for a novel genetic test that can determine whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). The SPOT-Light HER2 CISH kit uses chromogenic in situ hybridization (CISH) to quantify HER2 gene expression in tumor tissue. The approved test kit, Invitrogen’s first to receive PMA, will be available in mid-August.