%0 Journal Article
%T Analytical Validation and Application of a Targeted Next-Generation Sequencing Mutation-Detection Assay for Use in Treatment Assignment in the NCI-MPACT Trial
%A Alice P. Chen
%A Barbara A. Conley
%A Biswajit Das
%A Chih-Jian Lih
%A Courtney H. Bouk
%A David J. Sims
%A Eric C. Polley
%A James H. Doroshow
%A Kneshay N. Harper
%A Lawrence V. Rubinstein
%A Michele G. Mehaffey
%A Paul M. Williams
%A Richard M. Simon
%A Robin D. Harrington
%A Shivaani Kummar
%A Thomas D. Forbes
%A Vivekananda Datta
%A William D. Walsh
%A Yingdong Zhao
%J The Journal of Molecular Diagnostics
%D 2016
%R 10.1016/j.jmoldx.2015.07.006
%X 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¨CBased
Assignment of Cancer Therapy (NCI-MPACT) trial (NCT01827384). Using DNA samples from
normal or tumor cell lines and xenografts with known variants, we assessed the sensitivity,
specificity, and reproducibility of the NCI-MPACT assay in five variant types: single-nucleotide
variants (SNVs), SNVs at homopolymeric (HP) regions (¡Ý3 identical bases), small insertions/deletions
(indels), large indels (gap£¿¡Ý4 bp), and indels at HP regions.
%U https://jmd.amjpathol.org/article/S1525-1578(15)00218-4/fulltext