Caris Life Sciences® , a pioneer in precision medicine and next-generation AI-driven diagnostics, has published a new study in Oncotarget validating the analytical and clinical performance of MI Cancer Seek®. This FDA-approved companion diagnostic (CDx) is designed to help identify cancer patients who may benefit from targeted therapies.
MI Cancer Seek® is the first and only assay to integrate whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved CDx indications for solid tumor profiling in both adults and children—marking a milestone in precision oncology.
The study confirmed that MI Cancer Seek reliably detects multiple high-clinical-significance variants and adheres to rigorous laboratory standards. It supports eight CDx claims, covering high-burden cancer areas, and demonstrated strong performance compared to other FDA-approved assays, with 97%–100% agreement rates.
Unlike conventional tissue-based assays requiring separate DNA and RNA tests, MI Cancer Seek enables simultaneous RNA and DNA extraction from minimal tissue, saving precious samples and reducing delays.
“MI Cancer Seek provides a comprehensive molecular blueprint without compromising tissue or accuracy. These results highlight our dedication to scientific rigor and validation,” said David Spetzler, MS, PhD, MBA, President of Caris.
Dr. George W. Sledge, Jr., EVP and Chief Medical Officer, added:
“By embedding CDx tests into broad biomarker panels, we maximize tissue efficiency and help more patients access personalized treatment options.”
MI Cancer Seek is an advanced NGS-based in vitro diagnostic (IVD) using tumor tissue specimens to detect SNVs, indels, MSI, TMB, and copy number amplifications. It is intended to guide therapy selection by identifying patients eligible for FDA-approved targeted treatments and to provide comprehensive molecular profiling in line with oncology guidelines.