Discrepancies in Clinical Laboratory Testing of Eligibility for Trastuzumab Therapy: Apparent Immunohistochemical False-Positives Do Not Get the Message

Abstract excerpt

BACKGROUND: Several studies have reported what seem to be false-positive results using the Food and Drug Administration (FDA)-approved HercepTest (Dako Corp, Carpinteria, CA) to profile Her-2/neu amplification and overproduction in breast carcinoma. False-positive status has been based on comparisons with gene copy enumeration by fluorescence in situ hybridization (FISH) and with comparisons to...

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