Oncotarget

Research Papers:

Clinical validation of the tempus xT next-generation targeted oncology sequencing assay

Nike Beaubier _, Robert Tell, Denise Lau, Jerod R. Parsons, Stephen Bush, Jason Perera, Shelly Sorrells, Timothy Baker, Alan Chang, Jackson Michuda, Catherine Iguartua, Shelley MacNeil, Kaanan Shah, Philip Ellis, Kimberly Yeatts, Brett Mahon, Timothy Taxter, Martin Bontrager, Aly Khan, Robert Huether, Eric Lefkofsky and Kevin P. White

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Oncotarget. 2019; 10:2384-2396. https://doi.org/10.18632/oncotarget.26797

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Abstract

Nike Beaubier1, Robert Tell1, Denise Lau1, Jerod R. Parsons1, Stephen Bush1, Jason Perera1, Shelly Sorrells1, Timothy Baker1, Alan Chang1, Jackson Michuda1, Catherine Iguartua1, Shelley MacNeil1, Kaanan Shah1, Philip Ellis1, Kimberly Yeatts1, Brett Mahon1, Timothy Taxter1, Martin Bontrager1, Aly Khan1, Robert Huether1, Eric Lefkofsky1 and Kevin P. White1

1Tempus Labs Inc., Chicago, IL 60654, USA

Correspondence to:

Nike Beaubier, email: nike.beabier@tempus.com

Kevin P. White, email: kevin@tempus.com

Keywords: tumor profiling, next-generation sequencing assay validation

Received: August 03, 2018     Accepted: February 03, 2019     Published: March 22, 2019

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.


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