Comparison of automated and manual FISH for evaluation of HER2 gene status on breast carcinoma core biopsies

Öhlschlegel, Christian; Kradolfer, Doris; Hell, M.; Jochum, Wolfram

doi:10.1186/1472-6890-13-13

Cited by 19 publications

(24 citation statements)

References 14 publications

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“…evaluated an automated HER2 FISH assay with core biopsy specimens of 100 invasive breast carcinomas using the automated Leica HER2 FISH system and compared the results with the Abbott Molecular PathVysion HER‐2 DNA dual‐colored Probe Kit. When they analyzed 30IHC 2+ cases, the concordance rate was 93.3%, which shows reliable agreement between the two FISH methods.…”

Section: Discussionmentioning

confidence: 83%

Analysis of HER2 status in breast carcinoma by fully automated HER2 fluorescence in situ hybridization (FISH): comparison of two immunohistochemical tests and manual FISH

Yoon

Cho

2013

APMIS

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Easy and accurate HER2 testing is essential when considering the prognostic and predictive significance of HER2 in breast cancer. The use of a fully automated, quantitative FISH assay would be helpful to detect HER2 amplification in breast cancer tissue specimens with reduced inter-laboratory variability. We compared the concordance of HER2 status as assessed by an automated FISH staining system to manual FISH testing. Using 60 formalin-fixed paraffin-embedded breast carcinoma specimens, we assessed HER2 immunoexpression with two antibodies (DAKO HercepTest and CB11). In addition, HER2 status was evaluated with automated FISH using the Leica FISH System for BOND and a manual FISH using the Abbott PathVysion DNA Probe Kit. All but one specimen were successfully stained using both FISH methods. When the data were divided into two groups according to HER2/CEP17 ratio, positive and negative, the results from both the automated and manual FISH techniques were identical for all 59 evaluable specimens. The HER2 and CEP17 copy numbers and HER2/CEP17 ratio showed great agreement between both FISH methods. The automated FISH technique was interpretable with signal intensity similar to those of the manual FISH technique. In contrast with manual FISH, the automated FISH technique showed well-preserved architecture due to low membrane digestion. HER2 immunohistochemistry and FISH results showed substantial significant agreement (κ = 1.0, p < 0.001). HER2 status can be reliably determined using a fully automated HER2 FISH system with high concordance to the well-established manual FISH method. Because of stable signal intensity and high staining quality, the automated FISH technique may be more appropriate than manual FISH for routine applications.

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Section: Discussionmentioning

confidence: 83%

Analysis of HER2 status in breast carcinoma by fully automated HER2 fluorescence in situ hybridization (FISH): comparison of two immunohistochemical tests and manual FISH

Yoon

Cho

2013

APMIS

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“…Software-based systems for automated detection of HER2 gene amplification status in breast cancer samples have already been developed [34][35][36] , all based on conventional image analysis algorithms. These software solutions are strictly dependent on accurate preparation of the FISH slides, which otherwise could not be well analyzed by the software pipeline.…”

Section: Discussionmentioning

confidence: 99%

Automated detection of the HER2 gene amplification status in Fluorescencein situhybridization images for the diagnostics of cancer tissues

Zakrzewski

Back

Weigert

et al. 2018

Preprint

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The human epidermal growth factor receptor 2 (HER2) gene amplification status is a crucial marker for evaluating clinical therapies of breast or gastric cancer. We propose a deep learningbased pipeline for the detection, localization and classification of interphase nuclei depending on their HER2 gene amplification state in Fluorescence in situ hybridization (FISH) images. Our pipeline combines two RetinaNetbased object localization networks which are trained (1) to detect and classify interphase nuclei into distinct classes normal, low-grade and high-grade and (2) to detect and classify FISH signals into distinct classes HER2 or centromere of chromosome 17 (CEN17). By independently classifying each nucleus twice, the two-step pipeline provides both robustness and interpretability for the automated detection of the HER2 amplification status. The accuracy of our deep learning-based pipeline is on par with that of three pathologists and FISH images on a set of 57 validation images containing several hundreds of nuclei are accurately classified. The automatic pipeline is a first step towards assisting pathologists in evaluating the HER2 status of tumors using FISH images, for analyzing FISH images in retrospective studies, and for optimizing the documentation of each tumor sample by automatically annotating and reporting of the HER2 gene amplification specificities.

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“…For instance, a recent position paper advocates that accurate assessment of common morphological end points in lung (e.g., alveolar number or size) requires the application of 3-D stereology (Hsia et al 2010). However, while mandated use of 3-D measurements may be justified in some settings, several recent studies across various disease indications in humans have shown that 2-D tIA of digital images yields data sets that are (1) concordant with scores acquired by conventional manual evaluation and diagnostic scoring and (2) at times provide an even more accurate measurement for the severity and stage of a disease (Daunoravicius et al 2014;Zhong et al 2016;Laurinaviciene et al 2011;Turashvili et al 2009;Vennalaganti et al 2015;Lee et al 2013;Farris et al 2014;Snead et al 2016;Ohlschlegel et al 2013). The utility of 2-D tIA gains additional importance in tissue specimens harvested in the course of human clinical trials because 2-D digital imaging approaches still provide useful information when tissue sample sizes are too small (e.g., needle core biopsies) to permit 3-D evaluation or when ethical considerations preclude optimal processing of tissue (i.e., euthanasia with rapid removal and fixation of tumor-ridden organs as practiced in animal experiments is not possible in human patients).…”

Section: Discussionmentioning

confidence: 99%

Commentary

Aeffner¹,

Wilson²,

Bolon³

et al. 2016

Toxicol Pathol

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Historically, pathologists perform manual evaluation of H&E-or immunohistochemically-stained slides, which can be subjective, inconsistent, and, at best, semiquantitative. As the complexity of staining and demand for increased precision of manual evaluation increase, the pathologist's assessment will include automated analyses (i.e., ''digital pathology'') to increase the accuracy, efficiency, and speed of diagnosis and hypothesis testing and as an important biomedical research and diagnostic tool. This commentary introduces the many roles for pathologists in designing and conducting high-throughput digital image analysis. Pathology review is central to the entire course of a digital pathology study, including experimental design, sample quality verification, specimen annotation, analytical algorithm development, and report preparation. The pathologist performs these roles by reviewing work undertaken by technicians and scientists with training and expertise in image analysis instruments and software. These roles require regular, face-to-face interactions between team members and the lead pathologist. Traditional pathology training is suitable preparation for entry-level participation on image analysis teams. The future of pathology is very exciting, with the expanding utilization of digital image analysis set to expand pathology roles in research and drug development with increasing and new career opportunities for pathologists.

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Comparison of automated and manual FISH for evaluation of HER2 gene status on breast carcinoma core biopsies

Cited by 19 publications

References 14 publications

Analysis of HER2 status in breast carcinoma by fully automated HER2 fluorescence in situ hybridization (FISH): comparison of two immunohistochemical tests and manual FISH

Analysis of HER2 status in breast carcinoma by fully automated HER2 fluorescence in situ hybridization (FISH): comparison of two immunohistochemical tests and manual FISH

Automated detection of the HER2 gene amplification status in Fluorescencein situhybridization images for the diagnostics of cancer tissues

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