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Standard Reference Material for Her2 Testing: Report of a National Institute of Standards and Technology-Sponsored Consensus Workshop

Published

Author(s)

M E. Hammond, Peter E. Barker, S Taube, S Gutman

Abstract

A workshop was sponsored by National Institute of Standards and Technology (NIST) Cancer Diagnosis Program of National Cancer Institute (CDP NCI), Food and Drug Administration (FDA), and College of American Pathologists (CAP) to address the need for a reference material for Her2 gene protein testing. It was agreed that such a standard was desirable and necessary to assure the reliability of Her2 testing to qualify patients for trastuzumab therapy. Two standards consisting of well-characterized cell lines will be produced; one which will be a NIST certifiable standard and one will be commercially developed standards for use in all Her2 testing. It was also agreed that all Her2 testing must be done on samples fixed only in 10% buffered formalin, as specified in the FDA approved testing methods. Participants agreed to plan strategies to educate pathologists, clinicians and laboratories about the need and use of such a standard. A National
Citation
Applied Immunohistochemistry & Molecular Morphology
Volume
11
Issue
2

Keywords

breast cancer testing, Her2, SRM

Citation

Hammond, M. , Barker, P. , Taube, S. and Gutman, S. (2003), Standard Reference Material for Her2 Testing: Report of a National Institute of Standards and Technology-Sponsored Consensus Workshop, Applied Immunohistochemistry & Molecular Morphology (Accessed February 21, 2024)
Created May 31, 2003, Updated October 12, 2021