Caris Life Sciences Gains FDA Approval for MI Cancer Seek as a Companion Diagnostic Test

Caris Life Sciences (Caris) has received U.S. Food and Drug Administration (FDA) approval for the MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. 

“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.”

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. MI Cancer Seek is available for adults and pediatric patients ages 1-22.

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

MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies that are approved by therapeutic product labeling. MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals according to professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for the labeled use of any specific therapeutic product.

Companion Diagnostic Indications

Breast Cancer, biomarkers PIK3CA (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) with the PIQRAY (alpelisib) therapy.

Colorectal Cancer with biomarkers KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) using VECTIBIX (panitumumab) therapy or biomarkers BRAF V600E with the BRAFTOVI (encorafenib) in combination with ERBITUX (cetuximab) therapies. 

Melanoma, biomarkers BRAF V600E using BRAF Inhibitors approved therapies, or biomarkers BRAF V600E or V600K with the MEKINIST (trametinib) or BRAF/MEK Inhibitor Combinations approved by FDA therapies. 

Non-Small Cell Lung Cancer with biomarkers EGFR exon 19 deletions and exon 21 L858R alterations using EGFR Tyrosine Kinase Inhibitors approved by FDA therapies. 

Solid Tumors with MSI-H biomarkers using KEYTRUDA (pembrolizumab), JEMPERLI (dostarlimab-gxly) therapies. 

Endometrial Carcinoma with not MSI-H biomarkers using KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) therapies. 

“We are very excited to receive FDA approval for our MI Cancer Seek test. The extensive rigor with which the FDA evaluates new technology ensures patients have access to safe and effective tests,” said Caris President David Spetzler, MS, PhD, MBA. “The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”