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

• Caris Life Sciences' MI Cancer Seek receives FDA approval as a companion diagnostic for targeted cancer therapies, benefiting both adult and pediatric patients.
• MI Cancer Seek is the first assay to simultaneously use Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with FDA-approved CDx indications.
• The diagnostic tool identifies single nucleotide variants, insertions, deletions, microsatellite instability, and tumor mutational burden in solid tumors.
• MI Cancer Seek supports treatment decisions across multiple cancers, including breast, colorectal, melanoma, non-small cell lung cancer, and endometrial carcinoma.

Caris Life Sciences has announced that its MI Cancer Seek assay has received FDA approval as a companion diagnostic (CDx) to identify cancer patients who may benefit from targeted therapies. The approval encompasses both adult and pediatric patients (ages 1-22) and includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies.

First-of-its-Kind Diagnostic Tool

MI Cancer Seek is the first and only assay to simultaneously utilize Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) with FDA-approved CDx indications for molecular profiling of solid tumors. This next-generation sequencing (NGS)-based in vitro diagnostic (IVD) device uses total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens.

The assay detects 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.

Clinical Applications and Biomarkers

MI Cancer Seek is designed to identify patients who may benefit from specific targeted therapies, in accordance with approved therapeutic product labeling. The companion diagnostic indications include:

• Breast Cancer: PIK3CA mutations (C420R; E542K; E545A, E545D, E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) to identify patients for PIQRAY® (alpelisib) treatment.
• Colorectal Cancer (CRC): KRAS and NRAS wild-type status for VECTIBIX® (panitumumab) and BRAF V600E mutations for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab).
• Melanoma: BRAF V600E or V600K mutations for BRAF inhibitors or MEKINIST® (trametinib) or BRAF/MEK inhibitor combinations.
• Non-Small Cell Lung Cancer (NSCLC): EGFR exon 19 deletions and exon 21 L858R alterations for EGFR tyrosine kinase inhibitors.
• Solid Tumors: MSI-H for KEYTRUDA® (pembrolizumab) or JEMPERLI (dostarlimab-gxly).
• Endometrial Carcinoma: Not MSI-H for KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib).

Expert Commentary

"FDA approval of MI Cancer Seek – the first of its kind – further demonstrates Caris' continued leadership in molecular science and our extreme focus on quality," said Caris Chairman, Founder and CEO David Dean Halbert, DSc (h.c.). "We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools."

Caris President David Spetzler, MS, PhD, MBA, added, "The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests. The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies."

Streamlined NGS Process

Typically, DNA and RNA analysis by NGS requires two separate testing processes, potentially demanding more tissue and time. MI Cancer Seek combines WES and WTS into one workflow, providing a comprehensive molecular blueprint while conserving tissue. Further details, including companion diagnostic information and performance characteristics, are available at www.CarisLifeSciences.com/MICancerSeek.