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. 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 Autostainer 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 Dako Denmark A/S.