Reclassify HER2 Status

HERmark® enables physicians to classify HER-2 status with a new level of confidence. The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines recommend that HER-2 status be determined for all invasive breast cancer patients. These guidelines caution that current HER-2 testing methods (central immunohistochemistry [IHC] and fluorescent in situ hybridization [FISH]) may be inaccurate in up to 20% of cases.1,2

The HERmark Breast Cancer Assay precisely quantifies HER-2 total protein levels in formalin-fixed paraffin-embedded (FFPE) samples. HERmark reclassified up to 23% of samples from a cohort of the FinHer Adjuvant Breast Cancer Study.3