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Use of Highly Multiplexed Reference Materials to Facilitate Validation of a Clinical NGS Tumor Fusion RNA Test

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American Assocation for Cancer Research (AACR) | Chicago, Illinois 2018

Catherine Huang, Subit Barua, Deepika Philkana, Russell Garlick, Bharathi Anekella, and Helen Fernandes

next-generation sequencing (NGS) assays for detection of tumor RNA fusions must undergo rigorous validation before clinical implementation. Validations include assessment of the assay’s accuracy, precision, reproducibility, and limits of detection (LOD) or reportable range. Obtaining samples with all needed variants is difficult and time consuming. When found, they are often in limited quantities such that repeated testing for precision and reproducibility studies is not possible. Sample heterogeneity or lack of characterization further complicates interpretation of results. This study demonstrates how highly characterized, uniformly manufactured reference materials can facilitate clinical NGS assay validation.

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