Aim-To evaluate the clinical usefulness of three commercially available assays for Her-2/neu oncogene and protein measurements. The Her-2/neu protein is overexpressed, mostly as a result of gene amplification, in 20-30% of human breast cancers, and has been shown to have prognostic and predictive value for treatment with chemotherapy or the new monoclonal antibody, Herceptin. Methods-An immunohistochemistry (IHC) assay using the Dako polyclonal antibody A0485, which measures the Her-2/neu protein, was compared with two new Food and Drug Administration (FDA) approved fluorescence in situ hybridisation (FISH) assays-INFORM™ and PathVysion™, in a cohort of 52 formalin fixed, paraYn wax embedded breast tissues. These tissues were selected randomly from 84 consecutive infiltrating breast cancer specimens, which were first stratified according to the Her-2/neu protein levels as measured by IHC. Results-The two FISH assays achieved a 98% concordance rate: 14 specimens (27%) showed Her-2/neu gene amplification and 37 specimens (71%) showed no Her-2/neu gene amplification. The PathVysion assay had certain advantages over the INFORM assay. In contrast, the IHC assay detected Her-2/neu overexpression in a high percentage of cases, including 13 high positive specimens (25%) and 13 medium positive specimens (25%). Although 10 of these 13 IHC high positive specimens showed gene amplification by FISH, nine of 13 IHC medium positive specimens showed no gene amplification. Statistical analyses showed that the diVerences between IHC and FISH assays were primarily in the specimens with medium positive IHC, but negative FISH results. Conclusions-Because of the increasing importance of the Her-2/neu oncogene and oncoprotein in the clinical management of patients with breast cancer, the accurate and consistent evaluation of Her-2/neu status is crucial. This study suggests that the best approach is to combine both IHC and FISH assays; that is, to use the IHC assay as a triage step, followed by the PathVysion FISH assay to analyse the IHC medium and high positive cases.(J Clin Pathol 2000;53:374-381)

HER-2/neu protein overexpression in breast cancer is mostly caused by HER-2/neu gene amplification. However, it is unclear whether aneusomy 17 may also play a role. Using immunohistochemistry assay (IHC) with DAKO antibody and manual quantitation, 189 specimens were selected from archival invasive breast cancer specimens, including most IHC-positive and some IHC-negative cases (n ‫؍‬ 158 and 31, respectively).

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BACKGROUND.Bile duct brushing cytology is a common procedure for the exclusion of adenocarcinoma in the bile duct. The authors evaluated the use of ThinPrep (TP) to determine whether the information obtained is equivalent to that found with conventional smear cytology (CS). METHODS.Thirty-eight prospectively collected endoscope retrograde cholangiopancreatography-guided bile duct brushing samples were split in the following manner. First, two to four CS were prepared and immediately spray-fixed or wet-fixed. Second, the remaining sample was rinsed in PreservCyt™ (Cytyc Corp., Boxborough, MA). In the laboratory, one TP slide was prepared from each sample.TP and CS were stained by routine Papanicolaou stain. For the current study, TP and CS were reviewed independently by two cytopathologists. The diagnoses made by the two methods were compared with the final histology. RESULTS.The cytologic diagnoses for both TP and CS were categorized into five main groups: 1) unsatisfactory, 2) negative, 3) reactive, 4) suspicious for malignancy, and 5) malignant. The diagnoses on the 38 TP bile duct brushings and CS were categorized as follows: 1) unsatisfactory-2, 4; 2) negative-7, 4; 3) reactive-10, 14; 4) suspicious for malignancy-9, 9; and 5) malignant-10, 7, respectively. Histologic follow-up was available in 14 cases (reactive-4, suspicious for malignancy-1, and malignant-9). The sensitivity was 77% for TP and 66% for CS. The specificity was 100% for both methods.CONCLUSIONS. The two methods described in the current study detected equivalent disease on bile duct brushings. TP was found to provide better preservation and cytologic detail. However, the diagnostic criteria may require modification. Cancer (Cancer Cytopathol)