Summary: Caris Life Sciences’ MI Cancer Seek, a new CDx assay, received FDA approval to help identify cancer patients who may benefit from targeted therapies.

Takeaways:

  1. Pioneering CDx Technology: MI Cancer Seek is the first FDA-approved test to use both whole exome sequencing (WES) and whole transcriptome sequencing (WTS) for molecular profiling, providing broad coverage for solid tumors.
  2. Comprehensive Targeting: The assay covers one pan-cancer and five tumor-specific indications, aiding in precise patient selection for multiple FDA-approved therapies.
  3. Wide Accessibility: Approved for adults and pediatric patients aged 1-22, MI Cancer Seek offers critical insights for personalized treatment options in precision oncology.

Caris Life Sciences (Caris), a next-generation AI TechBio company and provider in precision medicine, announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. 

A New CDx for Cancer Patients

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.

“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,” says 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.”

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.

Identifying Who Will Benefit from Targeted Therapies

MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the companion diagnostic indications table below, in accordance with the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with 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 labeled use of any specific therapeutic product.

“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,” says 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.”

 MI Cancer Seek Companion Diagnostic Indications

IndicationBiomarkerTherapy
  Breast Cancer PIK3CA (C420R; E542K; E545A, E545D [1635G>T only],
E545G, E545K, Q546E, Q546R; and H1047L, H1047R, 
H1047Y)		PIQRAY (alpelisib)
Colorectal Cancer 
(CRC) 		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)		VECTIBIX (panitumumab)
BRAF V600EBRAFTOVI (encorafenib) in combination with ERBITUX 
(cetuximab)
Melanoma BRAF V600EBRAF Inhibitors approved by FDA* 
BRAF V600E or V600KMEKINIST (trametinib) or BRAF/MEK Inhibitor 
Combinations approved by FDA*
Non-Small Cell Lung 
Cancer (NSCLC)		EGFR exon 19 deletions and exon 21 L858R alterationsEGFR Tyrosine Kinase Inhibitors approved by FDA*
Solid TumorsMSI-HKEYTRUDA (pembrolizumab), JEMPERLI (dostarlimab-gxly)
Endometrial 
Carcinoma		Not MSI-HKEYTRUDA (pembrolizumab) in combination with 
LENVIMA (lenvatinib)
*For the most current information about the device indications for the therapeutic products in this group, go to: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools#Group_Labeling

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