Caris Life Sciences Demonstrates Scientific Rigor with Clinical Validation of FDA-Approved MI Cancer Seek®

Core Insights - Caris Life Sciences has published a study validating the performance of MI Cancer Seek, an FDA-approved assay for identifying cancer patients who may benefit from targeted therapies [1][2] - MI Cancer Seek is the first test to combine whole exome sequencing and whole transcriptome sequencing with FDA-approved companion diagnostic indications for solid tumors in both adult and pediatric patients, representing a significant advancement in precision oncology [1][3] Performance and Features - The study shows that MI Cancer Seek reliably detects multiple variant types of high clinical significance, with positive and negative percent agreement ranging from 97% to 100% compared to other FDA-approved assays [2] - The assay supports eight companion diagnostic claims, addressing high clinical burden areas and demonstrating strong performance [2] - MI Cancer Seek allows simultaneous RNA and DNA extraction from minimal tissue input, reducing tissue requirements and potential delays compared to other assays [2][3] Technological Innovation - MI Cancer Seek utilizes next-generation sequencing (NGS) and total nucleic acid (TNA) from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens to detect single nucleotide variants, insertions and deletions, microsatellite instability, tumor mutational burden, and copy number amplification [3] - The assay is intended to provide tumor mutational profiling for patients with previously diagnosed solid tumors, aligning with professional oncology guidelines [3] Company Overview - Caris Life Sciences is a leading AI TechBio company focused on precision medicine, developing innovative solutions to transform healthcare through comprehensive molecular profiling and advanced AI applications [5][6] - The company aims to combine extensive molecular information with data-driven insights to realize the potential of precision medicine for patients [6]