Article
Analytical Validation and Application of a Targeted Next-Generation Sequencing Mutation-Detection Assay for Use in Treatment Assignment in the NCI-MPACT Trial.
The Journal of molecular diagnostics : JMD - 1 Jan 2016
Lih Chih-Jian, Sims David J, Harrington Robin D, Polley Eric C, Zhao Yingdong, Mehaffey Michele G, Forbes Thomas D, Das Biswajit, Walsh William D, Datta Vivekananda, Harper Kneshay N, Bouk Courtney H, Rubinstein Lawrence V, Simon Richard M, Conley Barbara A, Chen Alice P, Kummar Shivaani, Doroshow James H, Williams Paul M
Abstract excerpt
Robust and analytically validated assays are essential for clinical studies. We outline an analytical validation study of a targeted next-generation sequencing mutation-detection assay used for patient selection in the National Cancer Institute Molecular Profiling-Based Assignment of Cancer Therapy (NCI-MPACT) trial (NCT01827384). Using DNA samples from normal or tumor cell lines and xenografts with known...
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