Caris Life Sciences, a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, 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 (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 (WTS) with FDA-approved CDx indications for solid tumor profiling in both adult and pediatric patients, marking a significant advancement in precision oncology.
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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 (CDx) 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.
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“MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results. The study results underscore our commitment to ongoing scientific integrity and validation,” said David Spetzler, MS, PhD, MBA, President of Caris. “Patients and physicians deserve this level of diligence and scientific rigor when selecting a molecular profiling assay to inform cancer treatment.”
“Broad-based biomarker panels are key to improving outcomes in precision medicine, yet many patients still miss out on comprehensive molecular profiling,” said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer. “By integrating companion diagnostic tests into multi-gene panels that make the most of tissue samples, we can reduce inefficiencies and potentially help more patients access personalized therapies.”
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies, in accordance with the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
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