HercepTest for Automated Link Platforms

HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest specifically demonstrates overexpression of HER2 protein. Positive or negative results aid in the classification of abnormal cells/tissues and provide a basis for Herceptin® treatment selection. Decision regarding Herceptin® treatment should be made within the context of the patient's clinical history. HercepTest is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is being considered and for breast cancer patients for whom PERJETA™ (pertuzumab) or KADCYLA™ (ado-trastuzumab emtansine) treatment is being considered (see Herceptin®, PERJETA™, and KADCYLA™ package inserts).

The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing different expression levels of HER2 protein, and detailed instructions. SK001 has been tailored especially for use on Dako Automated Link instruments.

HercepTest™, Herceptin®, PERJETA™, and KADCYLA™ are trademarks owned by Genentech, Inc. and/or F. Hoffmann-La Roche Ltd.; HercepTest is subject to an exclusive trademark license to Agilent Technologies, Inc.