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

Abstract

// Nike Beaubier 1 , Robert Tell 1 , Denise Lau 1 , Jerod R. Parsons 1 , Stephen Bush 1 , Jason Perera 1 , Shelly Sorrells 1 , Timothy Baker 1 , Alan Chang 1 , Jackson Michuda 1 , Catherine Iguartua 1 , Shelley MacNeil 1 , Kaanan Shah 1 , Philip Ellis 1 , Kimberly Yeatts 1 , Brett Mahon 1 , Timothy Taxter 1 , Martin Bontrager 1 , Aly Khan 1 , Robert Huether 1 , Eric Lefkofsky 1 and Kevin P. White 1 1 Tempus 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.