FDA Approves DAKO HercepTest for HER2 Overexpression | 合法醫療器材資訊網

HercepTest,whichisbasedonanimmunohistochemistry(IHC)antibodyassay,iseasytoconductwithrelativelyfewstepsandequipmentroutinelyfoundin ...

The era of pharmacogenomics is upon us. On September 25, Genentech, Inc. (South San Francisco, CA) received U.S. Food and Drug Administration approval for the first biotech drug for treating metastatic breast cancer. The drug, Herceptin, targets the HER2 gene expressed by about 25% of all breast cancer patients and which is believed to be responsible for the aggressiveness of certain types of breast cancer.

On the same day DAKO Corp. (Carpinteria, CA) received FDA approval for HercepTest, an in vitro assay for the HER2 gene. The timing was not a coincidence, since Genentech and DAKO had been collaborating on HercepTest since at least March 1998. Nevertheless, the approval of a gene-targeting drug and an assay for the drugs potential effectiveness on the same day marks the beginning of what should be an exciting trend: the emergence of gene-based therapies and genetic tests that predict the treatments ef...