Performance characteristics of the MammaPrint® breast cancer diagnostic gene signature

Personalized Medicine
Leonie J M J DelahayeAnnuska M Glas

Abstract

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. 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. 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. 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.

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Citations

Dec 17, 2016·Biomarker Insights·Inès J BeumerAnnuska M Glas
Apr 30, 2017·Breast Cancer Research and Treatment·Leonie J M J DelahayeAnnuska M Glas
Dec 31, 2015·Annals of Surgical Oncology·Paul BaronPat Whitworth
Mar 24, 2016·Breast Cancer Research and Treatment·Inès BeumerAnnuska Glas
Jul 28, 2016·Scandinavian Journal of Clinical and Laboratory Investigation. Supplementum·Larry J Kricka
Mar 26, 2020·Translational Oncology·Lorenza MittempergherUNKNOWN Annuska M Glas. Electronic address: Annuska.Glas@agendia.com

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Methods Mentioned

BETA
chip
biopsy

Software Mentioned

RASTER
Transbig
Adjuvant
MammaPrint
MINDACT

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