The FDA-Approved Breast Cancer HER2 Evaluation Kit (HercepTest; Dako) May Miss Some HER2-Positive Breast Cancers.

The FDA-Approved Breast Cancer HER2 Evaluation Kit (HercepTest; Dako) May Miss Some HER2-Positive Breast Cancers.

Am J Clin Pathol. 2019 Jan 21;:

Authors: Schneider F, Jin Y, Van Smaalen K, Gulbahce EH, Factor RE, Li X

Abstract
Objectives: Accurate evaluation of human epidermal growth factor receptor 2 (HER2) in breast cancer is critical.
Methods: HER2 fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) tests were performed on 52 cases using a US Food and Drug Administration (FDA)-approved kit (HercepTest, FDA kit) and a laboratory-developed test (LDT) with the HercepTest antibody and a Leica Bond automated stainer.
Results: By FISH, 22 were HER2 positive, 29 were negative, and one was equivocal. Of the 22 HER2 FISH-positive cases, five were negative by the FDA kit and none by LDT. The five discrepant cases were retested using the same FDA kit in another Clinical Laboratory Improvement Amendments-certified laboratory, and all five cases were still negative. None of the 29 HER2 FISH-negative cases were positive by the FDA kit or LDT. The overall IHC-FISH concordance rate was 90.4% for the FDA kit and 100% for the LDT.
Conclusions: The FDA kit may miss some HER2-positive cases. The LDT has a higher sensitivity and a higher concordance rate with FISH results.

PMID: 30668632 [PubMed - as supplied by publisher]

from A via a.sfakia on Inoreader http://bit.ly/2UcMR7j