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Her2CISH pharmDx kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the her2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine her2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The cish procedure is automated using dako autoslainerinstruments. Her2 cish pharmdx kit is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. Results from the her2 cish pharmdx kit are intended for use as an adjunct to the clinicopathologic informationcurrently used for estimating prognosis in stage ii, node-positive breast cancer patients.
Cancer:
Breast Cancer
Gene:
HER-2 (Human epidermal growth factor receptor 2)
Drug:
Herceptin (trastuzumab)
Method:
Chromogenic in situ hybridization (CISH)
Approvals
Date
Cancer
Gene
Drug
By