Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system

Rachel Stevens, Imad Almanaseer, Miguel Gonzalez, Derin Caglar, Ryan A. Knudson, Rhett P. Ketterling, Daniel S. Schrock, Thomas A. Seemayer, Julia A. Bridge

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)144-150
Number of pages7
JournalJournal of Molecular Diagnostics
Volume9
Issue number2
DOIs
StatePublished - Apr 2007

Fingerprint

erbB-2 Genes
Gene Amplification
Fluorescence In Situ Hybridization
Breast Neoplasms
Paraffin
Formaldehyde
Multicenter Studies
Therapeutics

ASJC Scopus subject areas

  • Molecular Biology

Cite this

Stevens, R., Almanaseer, I., Gonzalez, M., Caglar, D., Knudson, R. A., Ketterling, R. P., ... Bridge, J. A. (2007). Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system. Journal of Molecular Diagnostics, 9(2), 144-150. https://doi.org/10.2353/jmoldx.2007.060102

Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system. / Stevens, Rachel; Almanaseer, Imad; Gonzalez, Miguel; Caglar, Derin; Knudson, Ryan A.; Ketterling, Rhett P.; Schrock, Daniel S.; Seemayer, Thomas A.; Bridge, Julia A.

In: Journal of Molecular Diagnostics, Vol. 9, No. 2, 04.2007, p. 144-150.

Research output: Contribution to journalArticle

Stevens, R, Almanaseer, I, Gonzalez, M, Caglar, D, Knudson, RA, Ketterling, RP, Schrock, DS, Seemayer, TA & Bridge, JA 2007, 'Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system', Journal of Molecular Diagnostics, vol. 9, no. 2, pp. 144-150. https://doi.org/10.2353/jmoldx.2007.060102
Stevens, Rachel ; Almanaseer, Imad ; Gonzalez, Miguel ; Caglar, Derin ; Knudson, Ryan A. ; Ketterling, Rhett P. ; Schrock, Daniel S. ; Seemayer, Thomas A. ; Bridge, Julia A. / Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system. In: Journal of Molecular Diagnostics. 2007 ; Vol. 9, No. 2. pp. 144-150.
@article{77d0254fe17d4761b61136e8b5b87d8a,
title = "Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system",
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.",
author = "Rachel Stevens and Imad Almanaseer and Miguel Gonzalez and Derin Caglar and Knudson, {Ryan A.} and Ketterling, {Rhett P.} and Schrock, {Daniel S.} and Seemayer, {Thomas A.} and Bridge, {Julia A.}",
year = "2007",
month = "4",
doi = "10.2353/jmoldx.2007.060102",
language = "English (US)",
volume = "9",
pages = "144--150",
journal = "Journal of Molecular Diagnostics",
issn = "1525-1578",
publisher = "Association of Molecular Pathology",
number = "2",

}

TY - JOUR

T1 - Analysis of HER2 gene amplification using an automated fluorescence in situ hybridization signal enumeration system

AU - Stevens, Rachel

AU - Almanaseer, Imad

AU - Gonzalez, Miguel

AU - Caglar, Derin

AU - Knudson, Ryan A.

AU - Ketterling, Rhett P.

AU - Schrock, Daniel S.

AU - Seemayer, Thomas A.

AU - Bridge, Julia A.

PY - 2007/4

Y1 - 2007/4

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=34247843057&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34247843057&partnerID=8YFLogxK

U2 - 10.2353/jmoldx.2007.060102

DO - 10.2353/jmoldx.2007.060102

M3 - Article

VL - 9

SP - 144

EP - 150

JO - Journal of Molecular Diagnostics

JF - Journal of Molecular Diagnostics

SN - 1525-1578

IS - 2

ER -