1. Clinical validation of the tempus xT next-generation targeted oncology sequencing assay
- Author
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Kaanan P. Shah, Jason Perera, Eric Lefkofsky, Jerod Parsons, Aly Khan, Denise Lau, Catherine Iguartua, Robert Tell, Timothy Taxter, Martin Bontrager, Shelly Sorrells, Kimberly Yeatts, Stephen Bush, Jackson Michuda, Nike Beaubier, Shelley M. MacNeil, Kevin P. White, Alan Chang, Timothy Baker, Brett Mahon, Robert Huether, and Philip Ellis
- Subjects
0301 basic medicine ,Oncology ,medicine.medical_specialty ,Somatic cell ,Microsatellite instability ,Biology ,medicine.disease ,next-generation sequencing assay validation ,DNA sequencing ,tumor profiling ,Fusion gene ,Transcriptome ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,Copy-number variation ,Indel ,Gene ,Research Paper - Abstract
We developed and clinically validated a hybrid capture next generation sequencing assay to detect somatic alterations and microsatellite instability in solid tumors and hematologic malignancies. This targeted oncology assay utilizes tumor-normal matched samples for highly accurate somatic alteration calling and whole transcriptome RNA sequencing for unbiased identification of gene fusion events. The assay was validated with a combination of clinical specimens and cell lines, and recorded a sensitivity of 99.1% for single nucleotide variants, 98.1% for indels, 99.9% for gene rearrangements, 98.4% for copy number variations, and 99.9% for microsatellite instability detection. This assay presents a wide array of data for clinical management and clinical trial enrollment while conserving limited tissue.
- Published
- 2019