| Literature DB >> 31173928 |
Lorenza Mittempergher1, Leonie J M J Delahaye1, Anke T Witteveen1, Jacob B Spangler2, Fariet Hassenmahomed1, Sammy Mee2, Soufiane Mahmoudi1, Jiang Chen2, Simon Bao2, Mireille H J Snel1, Sandra Leidelmeijer1, Naomi Besseling1, Anne Bergstrom Lucas3, Carlos Pabón-Peña3, Sabine C Linn4, Christa Dreezen1, Diederik Wehkamp1, Bob Y Chan2, René Bernards5, Laura J van 't Veer6, Annuska M Glas7.
Abstract
Next-generation DNA sequencing is rapidly becoming an indispensable tool for genome-directed cancer diagnostics, but next-generation RNA sequencing (RNA-seq) is currently not standardly used in clinical diagnostics for expression assessment. However, multigene RNA diagnostic assays are used increasingly in the routine diagnosis of early-stage breast cancer. Two of the most widely used tests are currently available only as a central laboratory service, which limits their clinical use. We evaluated the use of RNA-seq as a decentralized method to perform such tests. The MammaPrint and BluePrint RNA-seq tests were found to be equivalent to the clinically validated microarray tests. The RNA-seq tests were highly reproducible when performed in different locations and were stable over time. The MammaPrint RNA-seq test was clinically validated. Our data demonstrate that RNA-seq can be used as a decentralized platform, yielding results substantially equivalent to results derived from the predicate diagnostic device.Entities:
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Year: 2019 PMID： 31173928 DOI： 10.1016/j.jmoldx.2019.04.007
Source DB: PubMed Journal: J Mol Diagn ISSN： 1525-1578 Impact factor: 5.568