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Pathology. 2006 Apr;38(2):120-4.

Chromogenic in situ hybridisation testing for HER2 gene amplification in breast cancer produces highly reproducible results concordant with fluorescence in situ hybridisation and immunohistochemistry.

Author information

1
Westmead Hospital, Sydney, NSW, Australia. Michaelb@icpmr.wsahs.nsw.gov.au

Abstract

AIMS:

The objective of this study was to evaluate the accuracy, ease of use and reproducibility of chromogenic in situ hybridisation (CISH) for HER2 testing by studying its inter-laboratory concordance in five Australian pathology laboratories.

METHODS:

The HER2 status of 49 breast cancers was determined by CISH twice in two different laboratories. Each sample had previously been tested by immunohistochemistry (IHC; 2+ and 3+ cases selected) and fluorescence in situ hybridisation (FISH). Participating laboratories were blinded to these test results. Oestrogen receptor (ER) status was also evaluated for each cancer.

RESULTS:

High correlation was observed between FISH and CISH results. No cases showing high gene amplification by FISH were scored as non-amplified by CISH (kappa coefficient = 1). High correlation was observed between IHC and CISH, all IHC 3+ samples showing amplification by CISH. Inter-laboratory CISH concordance was also good (kappa coefficient = 0.67). Fifty-six per cent of HER2-amplified samples tested ER positive, while 42% of ER-positive cases showed HER2 gene amplification, confirming that HER2 testing should not be confined to ER-negative breast cancers.

CONCLUSIONS:

These findings demonstrate that CISH is a robust test to assess HER2 status in breast cancer and therefore is an important addition to the HER2 testing algorithm.

PMID:
16581651
DOI:
10.1080/00313020600561518
[Indexed for MEDLINE]

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