Clinical Validation of the Tempus xO Assay

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Authors Nike Beaubier, Robert Tell, Robert Huether, Martin Bontrager, Stephen Bush, Jerod Parsons, Kaanan Shah, Tim Baker, Gene Selkov, Tim Taxter, Amber Thomas, Sam Bettis, Aly Khan, Denise Lau, Christina Lee, Matthew Barber, Marcin Cieslik, Casey Frankenberger, Amy Franzen, Ali Weiner, Gary Palmer, Robert Lonigro, Dan Robinson, Yi-Mi Wu, Xuhong Cao, Eric Lefkofsky, Arul Chinnaiyan, and Kevin P. White

We have developed a clinically validated NGS assay that includes tumor, germline and RNA sequencing. We apply this assay to clinical specimens and cell lines, and we demonstrate a clinical sensitivity of 98.4% and positive predictive value of 100% for the clinically actionable variants measured by the assay. We also demonstrate highly accurate copy number measurements and gene rearrangement identification.