Article
Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial.
The Journal of molecular diagnostics : JMD - 1 Mar 2017
Lih Chih-Jian, Harrington Robin D, Sims David J, Harper Kneshay N, Bouk Courtney H, Datta Vivekananda, Yau Jonathan, Singh Rajesh R, Routbort Mark J, Luthra Rajyalakshmi, Patel Keyur P, Mantha Geeta S, Krishnamurthy Savitri, Ronski Karyn, Walther Zenta, Finberg Karin E, Canosa Sandra, Robinson Hayley, Raymond Amelia, Le Long P, McShane Lisa M, Polley Eric C, Conley Barbara A, Doroshow James H, Iafrate A John, Sklar Jeffrey L, Hamilton Stanley R, Williams P Mickey
Abstract excerpt
The National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) trial is a national signal-finding precision medicine study that relies on genomic assays to screen and enroll patients with relapsed or refractory cancer after standard treatments. We report the analytical validation processes for the next-generation sequencing (NGS) assay that was tailored for regulatory compliant use in the trial....
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