HER2 Support Group Forums - View Single Post - here we go again: How inexact ER status testing is!!!

Lani · 08-08-2007, 06:56 PM

Jeffrey Ross, MD Albany Medical College, Dept. of Pathology

Clinical Cancer Research 13, 2831-2835, May 15, 2007. doi: 10.1158/1078-0432.CCR-06-2522
© 2007 American Association for Cancer Research

Standardizing Slide-Based Assays in Breast Cancer: Hormone Receptors, HER2, and Sentinel Lymph Nodes

Jeffrey S. Ross1, W. Fraser Symmans2, Lajos Pusztai3 and Gabriel N. Hortobagyi3
Authors' Affiliations: 1 Department of Pathology and Laboratory Medicine, Albany Medical College, Albany, New York, and Divisions of 2 Pathology and 3 Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Requests for reprints: Jeffrey S. Ross, Department of Pathology and Laboratory Medicine, Albany Medical College, 47 New Scotland Avenue, Albany, NY 12208. Phone: 518-262-5461; Fax: 518-262-8092; E-mail: rossj@mail.amc.edu.

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.

08-08-2007, 06:56 PM	#43
Lani Senior Member Join Date: Mar 2006 Posts: 4,780	here is his name and an abstract of a recent article he wrote on the topic Jeffrey Ross, MD Albany Medical College, Dept. of Pathology Clinical Cancer Research 13, 2831-2835, May 15, 2007. doi: 10.1158/1078-0432.CCR-06-2522 © 2007 American Association for Cancer Research Standardizing Slide-Based Assays in Breast Cancer: Hormone Receptors, HER2, and Sentinel Lymph Nodes Jeffrey S. Ross1, W. Fraser Symmans2, Lajos Pusztai3 and Gabriel N. Hortobagyi3 Authors' Affiliations: 1 Department of Pathology and Laboratory Medicine, Albany Medical College, Albany, New York, and Divisions of 2 Pathology and 3 Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas Requests for reprints: Jeffrey S. Ross, Department of Pathology and Laboratory Medicine, Albany Medical College, 47 New Scotland Avenue, Albany, NY 12208. Phone: 518-262-5461; Fax: 518-262-8092; E-mail: rossj@mail.amc.edu. 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.