High False-Negative Rate of <i>HER2</i> Quantitative Reverse Transcription Polymerase Chain Reaction of the Onco<i>type</i> DX Test: An Independent Quality Assurance Study

Abstract excerpt

PURPOSE: HER2 (ERBB2) status is an important prognostic and predictive marker in breast carcinoma. In recent years, Genomic Health (GHI), purveyors of the Oncotype DX test, has been separately reporting HER2 by reverse transcription polymerase chain reaction (RT-PCR) to oncologists. Because of the lack of independent evaluation, this quality assurance study was undertaken to define the concordance rate between...

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