TY - JOUR
T1 - Standardizing slide-based assays in breast cancer
T2 - Hormone receptors, HER2, and sentinel lymph nodes
AU - Ross, Jeffrey S.
AU - Symmans, W. Fraser
AU - Pusztai, Lajos
AU - Hortobagyi, Gabriel N.
PY - 2007/5/15
Y1 - 2007/5/15
N2 - Despite the rapid expansion of novel diagnostics designed to personalize breast cancer care, there remain several significant unmet needs for improving the accuracy and reliability of tests that are already in common daily clinical practice. For example, although immunohistochemistry has been the predominant method for measuring estrogen receptor and progesterone receptor status for over 15 years, this assay remains unstandardized and there is a widespread concern that inaccuracy in immunohistochemistry technique and interpretation is leading to an unacceptably high error rate in determining the true hormone receptor status. Similarly, there is considerable concern that both false-negative and false-positive result rates for testing for HER2 status are unacceptably high in current clinical practice. This commentary considers a variety of factors, including preanalytic conditions and slide-scoring procedures, and other variables that may be contributing to current testing error rates and why there is a great need for the standardization of these biomarker assay procedures to further enable the highest possible quality of care for newly diagnosed breast cancer patients.
AB - Despite the rapid expansion of novel diagnostics designed to personalize breast cancer care, there remain several significant unmet needs for improving the accuracy and reliability of tests that are already in common daily clinical practice. For example, although immunohistochemistry has been the predominant method for measuring estrogen receptor and progesterone receptor status for over 15 years, this assay remains unstandardized and there is a widespread concern that inaccuracy in immunohistochemistry technique and interpretation is leading to an unacceptably high error rate in determining the true hormone receptor status. Similarly, there is considerable concern that both false-negative and false-positive result rates for testing for HER2 status are unacceptably high in current clinical practice. This commentary considers a variety of factors, including preanalytic conditions and slide-scoring procedures, and other variables that may be contributing to current testing error rates and why there is a great need for the standardization of these biomarker assay procedures to further enable the highest possible quality of care for newly diagnosed breast cancer patients.
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U2 - 10.1158/1078-0432.CCR-06-2522
DO - 10.1158/1078-0432.CCR-06-2522
M3 - Review article
C2 - 17504980
AN - SCOPUS:34249822213
SN - 1078-0432
VL - 13
SP - 2831
EP - 2835
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 10
ER -