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Caris Life Sciences Receives FDA Approval for Groundbreaking MI Cancer Seek™ Diagnostic Assay for Precision Oncology

NextEdge Admin

07 Nov 2024

1 min 48 sec

FDA,Precision Oncology,companion diagnostic

Caris Life Sciences® (Caris), a leader in AI-driven precision medicine, announced FDA approval of its MI Cancer Seek™ assay as a companion diagnostic (CDx) to guide treatment selection for cancer patients. MI Cancer Seek is the first FDA-approved CDx to use simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) for molecular profiling in solid tumors, covering one pan-cancer and five tumor-specific indications. It’s available for adults and pediatric patients (ages 1-22) and aligns with professional oncology guidelines.

This next-generation sequencing (NGS) in vitro diagnostic device analyzes total nucleic acid from formalin-fixed paraffin-embedded tumor tissue to detect 228 gene variants, microsatellite instability (MSI), tumor mutational burden (TMB), and copy number amplification in breast cancer cases. By identifying key biomarkers, MI Cancer Seek enables clinicians to match patients with targeted therapies, enhancing personalized treatment options.

Caris Chairman, Founder, and CEO David Dean Halbert expressed pride in bringing this groundbreaking tool to market, emphasizing the company’s commitment to advancing precision medicine. Caris President David Spetzler commended the FDA’s rigorous, collaborative review, which underscores the safety and efficacy of this novel diagnostic technology.