Caris Life Sciences publishes study in Oncotarget on MI Cancer Seek

Caris Life Sciences (CAI) has published a study in Oncotarget validating the analytical and clinical performance of MI Cancer Seek. This FDA-approved assay is used as a companion diagnostic, or CDx, to identify cancer patients who may benefit from targeted therapies. It includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only test to combine whole exome sequencing (WES) and whole transcriptome sequencing, or WTS, with FDA-approved CDx indications for solid tumor profiling in both adult and pediatric patients, marking a significant advancement in precision oncology. The study demonstrates that MI Cancer Seek works reliably for detecting multiple variant types of high clinical significance, and that its approved medical uses follow strict laboratory standards. The assay supports eight companion diagnostic claims, each addressing high clinical burden areas and demonstrating strong performance when compared to other FDA-approved assays, with positive and negative percent agreement ranging from 97% to 100%. MI Cancer Seek offers the added benefit of simultaneous RNA and DNA extraction from minimal tissue input compared to other tissue-based assays that may require individual testing processes for DNA and RNA and result in increased tissue requirements and potential delays. MI Cancer Seek is a next-generation sequencing, or NGS, based in vitro diagnostic device using total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens for the detection of single nucleotide variants and insertions and deletions in 228 genes, microsatellite instability, tumor mutational burden in patients with previously diagnosed solid tumors, and copy number amplification in one gene in patients with breast cancer.