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ER/PR pharmDx Kits are semi-quantitative immunohistochemical kit systems to identify estrogen receptor (ER) α protein and progesterone receptor (PR) protein expression in normal and neoplastic tissues. The assay specifically detects the ER α protein as well as the PR protein located in the cell nuclei of ER and PR-expressing cells, respectively. ER/PR pharmDx Kit is indicated as an aid in identifying patients eligible for treatment with anti-hormonal or aromatase inhibitor therapies as well as an aid in the prognosis and management of breast cancer. The kits utilize a simple two-step staining procedure and are suitable for formalin-fixed, paraffin-embedded specimens. The kits provide all the reagents needed to run the ER/PR tests, including control slides to validate each run, and detailed instructions.
Cancer:
Breast Cancer
Gene:
ER (Estrogen receptor), PGR (Progesterone receptor)
Method:
Immunohistochemistry (IHC)
Approvals
Date
Cancer
Gene
Drug
By
09/30/04
FDA