The Food and Drug Administration (FDA) has granted approval to Caris Life Sciences' MI Cancer Seek as a companion diagnostic (CDx) test for both adult and pediatric patients (ages 1-22) with cancer. This innovative test uses whole exome and transcriptome sequencing to identify patients who may benefit from targeted therapies. The approval, issued on November 6, 2024, marks a significant advancement in precision medicine, offering a more comprehensive and efficient approach to molecular profiling of solid tumors.
First Simultaneous Whole Exome and Transcriptome Sequencing CDx
MI Cancer Seek is the first and only assay to receive FDA approval for CDx indications that simultaneously uses whole exome sequencing and whole transcriptome sequencing in the molecular profiling of solid tumors. This next-generation sequencing-based in vitro diagnostic device uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens. It detects single nucleotide variants, insertions and deletions in 228 genes; microsatellite instability (MSI) and tumor mutational burden (TMB) in patients with previously diagnosed solid tumors; and copy number amplification in one gene in patients with breast cancer.
Clinical Applications and Targeted Therapies
This companion diagnostic is designed to identify patients who may benefit from treatment with specific targeted therapies, in accordance with the approved therapeutic product labeling. This includes:
- PIK3CA for treatment with Piqray (alpelisib) in breast cancer
- KRAS wild-type and NRAS wild type for treatment with Vectibix (panitumumab) in colorectal cancer
- BRAF V600E for treatment with Braftovi (encorafenib) in combination with Erbitux (cetuximab) in colorectal cancer
- BRAF V600E for treatment with BRAF Inhibitors approved by FDA in melanoma
- BRAF V600E or V600K for treatment with Mekinist (trametinib) or BRAF/MEK Inhibitor combinations approved by FDA in melanoma
- EGFR exon 19 deletions and exon 21 L858R alterations for treatment with EGFR Tyrosine Kinase Inhibitors approved by FDA in non–small cell lung cancer
- Microsatellite instability for treatment with Keytruda (pembrolizumab) and Jemperli (dostarlimab-gxly) in solid tumors
- Microsatellite instability for treatment with Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) in endometrial carcinoma
Additionally, the approval is intended to provide tumor mutational profiling that can be used in accordance with oncology guidelines for patients with previously diagnosed solid malignant neoplasms.
Streamlined Molecular Blueprint
Traditional DNA and RNA analysis via next-generation sequencing often requires two separate testing processes, potentially demanding more tissue and time. MI Cancer Seek addresses this by combining whole exome sequencing and whole transcriptome sequencing, delivering a comprehensive molecular blueprint while conserving tissue and time, without compromising the thoroughness of the results.
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 David Dean Halbert, chairman, founder and chief executive officer of Caris. "We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools."
Caris President David Spetzler added, "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."
