SlidePath Ltd., Swift Square, Northwood Business Park, Santry, Dublin 9, Ireland.
Histopathology. 2010 Jul;57(1):27-38. doi: 10.1111/j.1365-2559.2010.03577.x. Epub 2010 Jun 24.
Accurate determination of HER-2 status is critical to identify patients for whom trastuzumab treatment will be of benefit. Although the recommended primary method of evaluation is immunohistochemistry, numerous reports of variability in interpretation have raised uncertainty about the reliability of results. Recent guidelines have suggested that image analysis could be an effective tool for achieving consistent interpretation, and this study aimed to assess whether this technology has potential as a diagnostic support tool.
Across a cohort of 275 cases, image analysis could accurately classify HER-2 status, with 91% agreement between computer-aided classification and the pathology review. Assessment of the continuity of membranous immunoreactivity in addition to intensity of reactivity was critical to distinguish between negative and equivocal cases and enabled image analysis to report a lower referral rate of cases for confirmatory fluorescence in situ hybridization (FISH) testing. An excellent concordance rate of 95% was observed between FISH and the automated review across 136 informative cases.
This study has validated that image analysis can robustly and accurately evaluate HER-2 status in immunohistochemically stained tissue. Based on these findings, image analysis has great potential as a diagnostic support tool for pathologists and biomedical scientists, and may significantly improve the standardization of HER-2 testing by providing a quantitative reference method for interpretation.
准确确定 HER-2 状态对于识别将从曲妥珠单抗治疗中获益的患者至关重要。虽然推荐的主要评估方法是免疫组织化学，但许多关于解释变异性的报告引起了对结果可靠性的不确定性。最近的指南建议图像分析可能是实现一致解释的有效工具，本研究旨在评估该技术是否有可能成为诊断支持工具。
在 275 例病例的队列中，图像分析可以准确地分类 HER-2 状态，计算机辅助分类与病理审查之间的一致性为 91%。评估膜免疫反应的连续性以及反应强度对于区分阴性和不确定病例至关重要，使图像分析能够报告用于确认荧光原位杂交（FISH）检测的病例的转诊率较低。在 136 例有意义的病例中，FISH 与自动审查之间观察到极好的一致性，达到 95%。
本研究验证了图像分析可以稳健且准确地评估免疫组织化学染色组织中的 HER-2 状态。基于这些发现，图像分析具有作为病理学家和生物医学科学家的诊断支持工具的巨大潜力，并且通过提供用于解释的定量参考方法，可能会显著改善 HER-2 测试的标准化。
