MammaPrint乳腺癌诊断基因特征的性能特点。
Performance characteristics of the MammaPrint breast cancer diagnostic gene signature.
作者信息
Delahaye Leonie Jm, Wehkamp Diederik, Floore Arno N, Bernards Rene, Van't Veer Laura J, Glas Annuska M
机构信息
Department of Product Development & Support, Agendia NV, Science Park 406, 1098 XH Amsterdam, The Netherlands.
出版信息
Per Med. 2013 Nov;10(8):801-811. doi: 10.2217/pme.13.88.
BACKGROUND
The analytical performance of multigene signatures depends on many parameters, including precision, repeatability, reproducibility and intratumor heterogeneity. Indicators such as sensitivity, specificity, positive predictive value and negative predictive value are typically used to define the clinical performance of a diagnostic test.
AIM
Here we study these performance characteristics of the MammaPrint (Agendia NV, Amsterdam, The Netherlands) 70-gene signature using the US FDA-recommended guidelines, as well as predetermined acceptance criteria.
RESULTS
The clinical and analytical performance characteristics show that MammaPrint is a robust, reproducible, precise test, with a maximum variation of 5% in multiple samplings of the same tissue.
CONCLUSION
MammaPrint is a reliable indicator of distant metastasis in early-stage breast cancer patients of all ages and is well suited for personalized medical care.
背景
多基因特征的分析性能取决于许多参数，包括精密度、重复性、再现性和肿瘤内异质性。诸如敏感性、特异性、阳性预测值和阴性预测值等指标通常用于定义诊断测试的临床性能。
目的
在此，我们使用美国食品药品监督管理局（FDA）推荐的指南以及预先确定的验收标准，研究MammaPrint（荷兰阿姆斯特丹Agendia NV公司）70基因特征的这些性能特征。
结果
临床和分析性能特征表明，MammaPrint是一种稳健、可重复、精确的测试，同一组织的多次采样中最大变异为5%。
结论
MammaPrint是各年龄段早期乳腺癌患者远处转移的可靠指标，非常适合个性化医疗。
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