Caris Life Sciences' MI Cancer Seek Receives FDA Approval as Multicancer Companion Diagnostic

Key Insights

• Caris Life Sciences' MI Cancer Seek has gained FDA approval as a companion diagnostic for multiple cancer drugs across six cancer indications, enhancing personalized treatment strategies.
• The diagnostic tool utilizes simultaneous whole exome sequencing (WES) and whole transcriptome sequencing (WTS) for comprehensive molecular profiling of solid tumors in both adult and pediatric patients.
• MI Cancer Seek identifies patients who are most likely to benefit from therapies like Keytruda, Erbitux, Piqray, and Lenvima, marking a significant advancement in oncology.

The U.S. Food and Drug Administration (FDA) has granted approval to Caris Life Sciences' MI Cancer Seek as a companion diagnostic, capable of guiding treatment decisions across six different cancer types. This approval marks a significant step forward in personalized medicine, enabling clinicians to identify patients most likely to benefit from specific cancer therapies.

Broad Applicability Across Cancer Types

MI Cancer Seek is designed to identify patients with solid tumors, breast cancer, colorectal cancer (CRC), melanoma, non-small cell lung cancer (NSCLC), and endometrial carcinoma who are likely to respond positively to various cancer treatments. The companion diagnostic is intended to be used with established oncology drugs, including Merck & Co's Keytruda (pembrolizumab), Eli Lilly's Erbitux (cetuximab), Novartis' Piqray (alpelisib), and Eisai's Lenvima (lenvatinib).

Advanced Sequencing Technology

Caris Life Sciences touts MI Cancer Seek as the first and only assay to combine whole exome sequencing (WES) and whole transcriptome sequencing (WTS) with FDA-approved companion diagnostic indications for solid tumors. This comprehensive approach allows for detailed molecular profiling, enhancing the precision of treatment decisions. The FDA has approved its use for both adult and pediatric patients, spanning ages 1 to 22 years.

The diagnostic device is designed to detect single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), and tumor mutational burden (TMB) from nucleic acid isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens.

Growing Trend in Companion Diagnostics

The development and utilization of companion diagnostics have seen increased interest in recent years, particularly in oncology. These diagnostics play a crucial role in screening patients to determine their likelihood of benefiting from specific therapies. The market for oncology tests is projected to grow substantially, from $1.9 billion in 2022 to over $3.1 billion by 2030, according to GlobalData analysis.