ARUP Laboratories, a leading national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, today announced the availability of a new laboratory developed test designed to classify breast cancer into clinically significant molecular subtypes that are important for the management of the disease.
The new test is a RT-qPCR assay that measures the expression of 50 classifier genes and five control genes to identify the intrinsic subtypes known as Luminal A, Luminal B, HER2-enriched and Basal-like. Along with a categorical classification of breast cancer subtype, it also provides quantitative values for proliferation, luminal gene expression, ESR1, PGR and ERBB2. The test is listed in ARUP Laboratories' Laboratory Test Directory (LTD) as the PAM50 Breast Cancer Intrinsic Classifier™.
The PAM50 test offered by ARUP is the first clinical iteration of this gene expression signature, which has already been extensively validated in the research setting. "Although many gene sets have been used as surrogates for biologic subtyping of breast cancer, the PAM50 has proven to be a more accurate predictor of patient outcome than standard methods," said Philip Bernard, MD, medical director for the Molecular Pathology Laboratory at ARUP Laboratories and a co-inventor of the new assay.
The development of the PAM50 signature was the culmination of a decade of work that became a multi-institutional project with investigators from the University of Utah (Dr. Philip Bernard), the University of North Carolina at Chapel Hill (Dr. Charles Perou), the University of British Columbia (Dr. Torsten Nielsen), and the Washington University School of Medicine in St. Louis (Dr. Matthew Ellis).
Standard methods for diagnosing and treating breast cancer include anatomic staging, histological assessment, and molecular testing for ER, PR and HER2/neu protein expression. The PAM50 test is performed from formalin-fixed, paraffin-embedded tissues so that specimens are handled within routine clinical practice. "Having additional information about the tumor biology and quantitative data on biomarkers already used for treatment decisions is the first step towards personalized health care in oncology," said Bernard.
The PAM50 is the beginning of a suite of multi-analyte gene expression oncology tests offered by ARUP Laboratories and is complemented by other mutation tests (e.g., EGFR, KRAS and PIK3CA) that are already available.
"Our goal at ARUP Laboratories has always been to improve the quality and efficacy of medical care by providing accurate and actionable information derived from diagnostic laboratory tests," said Sherrie Perkins, MD, PhD, chief medical officer and director of laboratories at ARUP Laboratories. "This test represents our efforts to promote the right test for the right patient at the right time."
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