Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome sequencing-based comprehensive molecular profiling assay
Valeriy Domenyuk, Kasey Benson, Peggy Carter, Daniel Magee, Jian Zhang, Nitin Bhardwaj, Hongseok Tae, James Wacker, Foram Rathi, Siobhan Miick, Aastha Kohli, Joshua Carroll, Lori Cuyugan, Evelyn Perez, W.Z. Zhang, John M. Collins, Patrick Kennedy, Jeremy E. Ellis, Adam Stark, Andrey Loskutov, Brittany Cuttone, Blake Taylor, Rebecca Feldman, Jeff Swenson, David Bryant, Robert Hahn-Lowry, Raunaq Kaushal, Jennifer R. Ribeiro, Jim Abraham, Milan Radovich, George W. Sledge, Matthew J. Oberley, David Spetzler
Abstract
, an FDA-approved whole exome and whole transcriptome sequencing-based molecular test encompassing adult and pediatric tumor profiling, eight companion diagnostics (CDx), and additional laboratory developed test (LDT) capabilities. Patient tissue is maximized through simultaneous analysis of DNA and RNA with minimum input of 50 ng. The clinical and analytical validation presented herein demonstrates non-inferiority of MI Cancer Seek relative to other FDA-approved CDx tests (>97% negative and positive percent agreement), as well as its precision, sensitivity, and specificity. Accordingly, MI Cancer Seek represents a safe and effective comprehensive molecular test option supporting biomarker-directed care for oncology patients.