An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines.

Author(s): O'Grady A, Allen D, Happerfield L, Johnson N, Provenzano E, Pinder SE, Tee L, Gu M, Kay EW

Publication: Appl Immunohistochem Mol Morphol, 2010, Vol. 18, Page 489-93

PubMed ID: 20661132 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to compare results of HER2 immunostaining of FFPE breast cancer tissue using the Dako HercepTest and the Oracle HER2 Bond Immunohistochemical System. This study included a total of 445 archival FFPE breast cancer samples collected at 3 different centers. Specimens were obtained by needle core biopsy or resection, but no further details of specimen procurement or processing were provided. Sequential sections were stained using HercepTest and the Oracle on the Bond fully automated, advanced staining system. Staining was scored by blinded pathologists as each of the three sites as negative (0,1+), equivocal (2+), and positive (3+) according to the modified ASCO/CAP and UK HER2 IHC scoring guidelines. Forty-one specimens with discordant results were further evaluated using the PathVysion HER2 FISH staining system.

   Summary of Findings:

   Out of the original HercepTest positive and equivocal cases, 80.6% were identified as positive or equivocal by both the Oracle and HercepTest. 98.0% of the original negative cases were scored as negative by both the Oracle and HercerpTest. The overall concordance rate between the Oracle and HercepTest methods was 86.7%. A majority of discordant cases were scored as equivocal with the HercepTest and negative with Oracle IHC. In the majority of these cases (31/36), the HER2 gene was not amplified when analyzed by FISH. Use of modified ASCO/CAP and UK HER2 IHC scoring guidelines versus commercially validated HER2 IHC guidelines did not significantly influence concordance rates.

   Biospecimens

   • Tissue - Breast

   Preservative Types

   • Formalin

   Diagnoses:

   • Neoplastic - Carcinoma

   Platform:

   Analyte	Technology Platform
   Protein	Immunohistochemistry
   DNA	FISH

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Immunohistochemistry Specific	Targeted peptide/protein	HER2
   Immunohistochemistry Specific	Technology platform	Dako HercepTest Oracle HER2 Bond IHC System FISH

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