Chromogenic In Situ Hybridization Is a Reliable Method for Detecting HER2 Gene Status in Breast Cancer A Multicenter Study Using Conventional Scoring Criteria and the New ASCO/CAP Recommendations

Department of Pathology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA.
American Journal of Clinical Pathology (Impact Factor: 2.51). 05/2009; 131(4):490-7. DOI: 10.1309/AJCPI00TVGIGYXAA
Source: PubMed


Chromogenic in situ hybridization (CISH) has shown the potential to replace fluorescence in situ hybridization (FISH) to determine HER2 gene status. To validate the reliability of CISH, we used 226 consecutive breast carcinomas from 2 institutions and tested CISH and FISH on the same tumor set simultaneously at different test sites. Besides manufacturers' scoring criteria, the new American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines were used to interpret HER2 status. The concordance between CISH and FISH for positive and negative results was 98.5% at site A and 98.6% at site B using the manufacturers' criteria, and 99.0% at site A and 99.1% at site B using the ASCO/CAP criteria. Reproducibility of CISH results was more than 98.0% among 3 sites using the manufacturers' criteria and 100.0% between 2 sites using the ASCO/CAP criteria. Our results confirm that CISH is reliable for HER2 testing per ASCO/CAP guidelines.

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Available from: Lawrence Greenfield, Jan 05, 2016
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    • "<1.8), equivocal (1.8–2.2), and amplified (>2.2) according to ASCO/CAP guidelines [1] [13] "
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    • "They compared the results between FISH and CISH using the manufacturer's criteria (nonamplified and amplified) and the ASCO/CAP criteria (nonamplified, equivocal, and amplified). The concordance between CISH and FISH for positive and negative results was 98.5% and 98.6% at the two institutions using the manufacturers' criteria and 99% and 99.1% using the ASCO/CAP criteria [195]. The advantages of CISH include ability to analyze the test by light microscopy, preservation of morphologic features, permanent signals which will not fade with slide storage, lower reagent costs, and need for less expertise than FISH [193, 196]. "
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