MammaPrint molecular diagnostics on formalin-fixed, paraffin-embedded tissue.

Autor:	Sapino A; Department of Medical Sciences, University of Turin, Turin, Italy. Electronic address: anna.sapino@unito.it., Roepman P; Department of Research and Development, Agendia, Amsterdam, the Netherlands., Linn SC; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands., Snel MH; Department of Research and Development, Agendia, Amsterdam, the Netherlands., Delahaye LJ; Department of Product Development and Support, Agendia, Amsterdam, the Netherlands., van den Akker J; Department of Product Development and Support, Agendia, Amsterdam, the Netherlands., Glas AM; Department of Product Development and Support, Agendia, Amsterdam, the Netherlands., Simon IM; Department of Research and Development, Agendia, Amsterdam, the Netherlands., Barth N; Department of Medical Affairs, Agendia, Irvine, California., de Snoo FA; Department of Medical Affairs, Agendia, Amsterdam, the Netherlands., van 't Veer LJ; Department of Research and Development, Agendia, Amsterdam, the Netherlands., Molinaro L; Department of Medical Sciences, University of Turin, Turin, Italy., Berns EM; Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands., Wesseling J; Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands., Riley LB; Department of Surgical Oncology, St. Luke's Hospital and Health Network, Bethlehem, Pennsylvania., Anderson D; Department of Pathology, St. Luke's Hospital and Health Network, Bethlehem, Pennsylvania., Nguyen B; Department of Medicine, Todd Cancer Institute, Long Beach Memorial Medical Center, Long Beach, California., Cox CE; Department of Surgery, University of South Florida, Tampa, Florida.
Jazyk:	angličtina
Zdroj:	The Journal of molecular diagnostics : JMD [J Mol Diagn] 2014 Mar; Vol. 16 (2), pp. 190-7. Date of Electronic Publication: 2013 Dec 28.
DOI:	10.1016/j.jmoldx.2013.10.008
Abstrakt:	MammaPrint, a prognostic 70-gene profile for early-stage breast cancer, has been available for fresh tissue. Improvements in RNA processing have enabled microarray diagnostics for formalin-fixed, paraffin-embedded (FFPE) tissue. Here, we describe method optimization, validation, and performance of MammaPrint using analyte from FFPE tissue. Laboratory procedures for enabling the assay to be run on FFPE tissue were determined using 157 samples, and the assay was established using 125 matched FFPE and fresh tissues. Validation of MammaPrint-FFPE, compared with MammaPrint-fresh, was performed on an independent series of matched tissue from five hospitals (n = 211). Reproducibility, repeatability, and precision of the FFPE assay (n = 87) was established for duplicate analysis of the same tumor, interlaboratory performance, 20-day repeat experiments, and repeated analyses over 12 months. FFPE sample processing had a success rate of 97%. The MammaPrint assay using FFPE analyte demonstrated an overall equivalence of 91.5% (95% confidence interval, 86.9% to 94.5%) between the 211 independent matched FFPE and fresh tumor samples. Precision was 97.3%, and repeatability was 97.8%, with highly reproducible results between replicate samples of the same tumor and between two laboratories (concordance, 96%). Thus, with 580 tumor samples, MammaPrint was successfully translated to FFPE tissue. The assay has high precision and reproducibility, and FFPE results are substantially equivalent to results derived from fresh tissue. (Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu