FDA Approves Caris Life Sciences' MI Cancer Seek as Companion Diagnostic

Key Insights

• 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 companion diagnostic indications.
• The diagnostic tool identifies single nucleotide variants, microsatellite instability, and tumor mutational burden in solid tumors to guide treatment decisions.

Caris Life Sciences has announced that the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek™ as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors and is available for both adult and pediatric patients (ages 1-22).

Comprehensive Molecular Profiling

MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device that uses total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. It 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.

Companion Diagnostic Indications

MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies, in accordance with the approved therapeutic product labeling. Additionally, it provides tumor mutational profiling for use by qualified healthcare professionals, following professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. It has several companion diagnostic indications:

• Breast Cancer: Identifies PIK3CA mutations (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) for treatment with PIQRAY® (alpelisib).
• Colorectal Cancer (CRC): Determines KRAS and NRAS wild-type status for VECTIBIX® (panitumumab) treatment and identifies BRAF V600E mutations for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab).
• Melanoma: Detects BRAF V600E or V600K mutations for treatment with BRAF inhibitors, MEKINIST® (trametinib), or BRAF/MEK inhibitor combinations.
• Non-Small Cell Lung Cancer (NSCLC): Identifies EGFR exon 19 deletions and exon 21 L858R alterations for treatment with EGFR tyrosine kinase inhibitors.
• Solid Tumors: Assesses MSI-H status for KEYTRUDA® (pembrolizumab) or JEMPERLI (dostarlimab-gxly) treatment.
• Endometrial Carcinoma: Determines non-MSI-H status for KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) treatment.

Streamlined Workflow

Typically, DNA and RNA analysis by NGS requires two separate testing processes, which may require more tissue and time. By combining WES and WTS into one workflow, MI Cancer Seek provides a comprehensive molecular blueprint that saves tissue without compromising results.

"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."