The Hormone Receptor Laboratory at the University of Louisville is a clinical laboratory licensed by the Commonwealth of Kentucky (State) and the Health Care Financing Administration (Federal). Dr. James L. Wittliff founded the laboratory and is the licensed director.
Clinical Activities-The primary responsibility is to provide assays of clinical analytes, particularly estrogen and progestin receptors on biopsies from patients with breast, uterine and ovarian cancers. Results from these clinically approved tests are used in cancer management and are being correlated with results from emerging prognostic tests (proteases, growth factor receptors & oncogene protein products) and patient parameters collected in tumor registries in the Commonwealth of Kentucky. The goal is to develop a panel of solid tumor markers aiding the oncologist in selecting therapeutic approaches improving patient care.
Quality Assurance Programs-Initially with American Cancer Society and National Cancer Institute support, an International Quality Assurance Program was established to evaluate proficiency in analyses and reporting format for estrogen and progestin receptors. The first cooperative clinical trial groups to integrate this survey program into therapeutic protocols were the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the Southeastern Cancer Study Group (SECSG). Later the Southwest Oncology Group (SWOG), Eastern Cooperative Oncology Group (ECOG), Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG) utilized the expertise and QA programs for many treatment trials. After two decades in which more than 400 laboratories participated in these survey programs, the College of American Pathologists (CAP) now sponsors biannual shipments of reference materials for these tumor markers. Interlaboratory surveys were developed for putative prognostic factors, such as cathepsin D, urokinase-type plasminogen activator, its receptor (uPAR) and its inhibitor (PAI-1) as well as for EGF receptors and the protein product of the related oncogene HER-2/neu (c-erb B2).
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