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JMD 2007, Vol. 9, No. 2
Copyright © 2007 American Society for Investigative Pathology & Association for Molecular Pathology

Technical Advance

Analysis of HER2 Gene Amplification Using an Automated Fluorescence in Situ Hybridization Signal Enumeration System

Rachel Stevens*, Imad Almanaseer{dagger}, Miguel Gonzalez{dagger}, Derin Caglar{dagger}, Ryan A. Knudson{ddagger}, Rhett P. Ketterling{ddagger}, Daniel S. Schrock§, Thomas A. Seemayer* and Julia A. Bridge*¶||

From the Departments of Pathology/Microbiology, * Pediatrics, and Orthopaedic Surgery, || University of Nebraska Medical Center, Omaha, Nebraska; the Department of Pathology, {dagger} Advocate Lutheran General Hospital, Park Ridge, Illinois; the Department of Cytogenetics, {ddagger} Mayo Clinic, Rochester, Minnesota; and Abbott Laboratories Inc., § Des Plaines, Illinois

Abstract

The HER2 gene, amplified in 10 to 35% of invasive human breast carcinomas, has prognostic and therapeutic implications. Fluorescent in situ hybridization is one method currently used for assessing HER2 status, but fluorescent in situ hybridization involves the time-consuming step of manual signal enumeration. To address this issue, Vysis has developed an automated signal enumeration system, Vysis AutoVysion. A multicenter, blinded study was conducted on 39 formalin-fixed, paraffin-embedded invasive breast carcinoma specimens, including 20 HER2 nonamplified and 19 HER2 amplified (weakly to highly amplified), provided in duplicate to each study site for analysis. Calculation of the HER2/CEP17 ratio and the hands-on time of both manual and automated enumeration approaches were compared. Overall agreement of HER2 classification results (positive and negative) was 92.5% (196 of 212). The Vysis AutoVysion System requires manual enumeration for cases with scanner results within the ratio range of 1.5 to 3.0. When the data in this range are excluded, the agreement between manual and scanner results is 98.8% (169 of 171). The average Vysis AutoVysion System hands-on time per slide was 4.59 versus 7.47 minutes for manual signal enumeration (savings of 2.88 minutes/slide). These data suggest that the Vysis AutoVysion System can correctly classify specimens and may increase the overall efficiency of HER2 testing.






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Copyright © 2007 by the American Society for Investigative Pathology and the Association for Molecular Pathology.