Caris Life Sciences' MI Cancer Seek Receives FDA Approval as Companion Diagnostic
Key Insights
Caris Life Sciences (search)' MI Cancer Seek (search) has gained FDA approval as a companion diagnostic, marking a significant advancement in precision medicine.
The assay is designed to identify cancer (search) patients who may benefit from targeted therapies, offering a comprehensive molecular blueprint of solid tumors (search).
MI Cancer Seek (search) is the first FDA-approved assay to combine Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) simultaneously.
Caris Life Sciences (search), a next-generation AI TechBio company based in Irving, Texas, has announced that its MI Cancer Seek (search) assay has received approval from the U.S. Food and Drug Administration (FDA) as a companion diagnostic. This approval allows MI Cancer Seek to be used to identify cancer (search) patients who may benefit from treatment with specific targeted therapies.
Significance of FDA Approval
According to Caris Founder, Chairman, and CEO David Dean Halbert, the FDA approval of MI Cancer Seek (search) demonstrates the company's leadership in molecular science and focus on quality. The company aims to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools. Caris Life Sciences (search) President David Spetzler also noted that the FDA's rigorous evaluation process ensures patients have access to safe and effective tests.
About MI Cancer Seek
MI Cancer Seek (search) is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device that analyzes total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens. It detects single nucleotide variants (SNVs) and insertions and deletions in 228 genes, microsatellite instability (MSI), and tumor mutational burden (TMB) in patients with previously diagnosed solid tumors (search). Additionally, it identifies copy number amplification in one gene in patients with breast cancer (search).
The assay includes one pan-cancer (search) and five tumor-specific indications for numerous FDA-approved therapies. It is available for use in both adult and pediatric patients (ages 1-22).
Comprehensive Molecular Profiling
MI Cancer Seek (search) is the first and only FDA-approved assay to simultaneously use Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) for molecular profiling of solid tumors (search). By combining WES and WTS into a single workflow, MI Cancer Seek provides a comprehensive molecular blueprint while conserving tissue and time, which are often critical in cancer (search) diagnostics. Typically, DNA and RNA analysis by NGS requires two separate testing processes that may require more tissue and time.
The test is intended to provide tumor mutational profiling for use by qualified healthcare professionals in accordance with professional oncology guidelines for cancer (search) patients with previously diagnosed solid malignant neoplasms.