How can I help to ensure an accurate HER2 test result?
• A: HER2 testing should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance may result from the use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation and can lead to unreliable results.1,21 Assessment for HER2 expression or gene amplification should be performed by laboratories with demonstrated proficiency in the specific technology being utilized.1 Recent findings suggest the need to improve quality control measures in laboratories that use IHC assays, including periodic testing for concordance with FISH. These studies also suggest that large-volume reference laboratories performing HER2 tests are more reliable than small-volume laboratories.17,21 (Back to Top) • Adjuvant indications • Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negati