Standard Reference Material for Her2 Testing: Report of a National Institute of Standards and Technology-Sponsored Consensus Workshop
M E. Hammond, Peter E. Barker, S Taube, S Gutman
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
, Barker, P.
, Taube, S.
and Gutman, S.
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)