Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome sequencing-based comprehensive molecular profiling assay

Abstract

The precision oncology industry has evolved rapidly within the past two decades, although treatment selection remains a complex undertaking. Access to timely, accurate, and comprehensive molecular profiling data is imperative to improving patient outcomes within the expanding sphere of Food and Drug Administration (FDA)-approved targeted therapies. Caris Life Sciences has developed MI Cancer Seek^®, 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.