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Updated: Oct 24, 2025

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
Published on: May 9, 2025
[2021 update of the GEFPICS' recommendations for HER2 status assessment in invasive breast cancer in France]
Camille Franchet1, Lounes Djerroudi1, Aurélie Maran-Gonzalez1
1Groupe d'étude des facteurs pronostiques immunohistochimiques dans le cancer du sein, Unicancer, 101, rue de Tolbiac, 75654 Paris cedex 13, France.
Abstract:
The last international guidelines on HER2 determination in breast cancer have been updated in 2018 by the American Society of Clinical Oncology and College of American Pathologists, on the basis of a twenty-year practice and results of numerous clinical trials. Moreover, the emerging HER2-low concept for 1+ and 2+ non amplified breast cancers lead to refine French practices for HER2 status assessment. The GEFPICS group, composed of expert pathologists, herein presents the latest French recommendations for HER2 status evaluation in breast cancer, taking into account the ASCO/CAP guidelines and introducing the HER2-low concept. In the era of personalized medicine, HER2 status assessment remains one of the most important biomarkers in breast cancer and its quality guaranties the optimal patients' care. French pathologists' commitment in theranostic biomarker quality is more than ever required to provide the most efficient cares in oncology.

