FDA Approves Dako's CISH Companion Test for Herceptin | GenomeWeb

Originally published Dec. 13.

The US Food and Drug Administration has approved Dako's HER2 CISH pharmDx Kit for quantitatively determining HER2 status in tumors of breast cancer patients who are considering treatment with the drug Herceptin.

The chromogenic in situ hybridization method enables simultaneous evaluation of gene amplification and tumor tissue morphology. The kit assesses HER2 status in formalin-fixed, paraffin-embedded breast cancer tissue. Dako's CISH test is automated on its Autostainer instruments.

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