Caris Life Sciences has received FDA approval for its MI Cancer Seek as a companion diagnostic (CDx) test. This approval allows MI Cancer Seek to be used to identify cancer patients who are likely to benefit from specific targeted therapies. The assay is the first of its kind, utilizing simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) for molecular profiling of solid tumors in both adult and pediatric patients.
MI Cancer Seek is designed as an in vitro diagnostic (IVD) device that uses next-generation sequencing (NGS) to analyze total nucleic acid (TNA) from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens. It detects single nucleotide variants (SNVs), insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB), and copy number amplification (CNA) in one gene for breast cancer patients.
Companion Diagnostic Indications
MI Cancer Seek is indicated for identifying patients who may benefit from specific targeted therapies, as outlined in its companion diagnostic indications. These include:
- Breast Cancer: PIK3CA mutations (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) for PIQRAY (alpelisib).
- Colorectal Cancer (CRC): KRAS and NRAS wild-type for VECTIBIX (panitumumab); BRAF V600E for BRAFTOVI (encorafenib) in combination with ERBITUX (cetuximab).
- Melanoma: BRAF V600E for BRAF inhibitors; BRAF V600E or V600K for 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) and JEMPERLI (dostarlimab-gxly).
- Endometrial Carcinoma: Not MSI-H for KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib).
Streamlined Workflow
Traditional NGS methods often require separate DNA and RNA analyses, which can demand more tissue and time. MI Cancer Seek streamlines this process by combining WES and WTS into a single workflow, conserving tissue while providing comprehensive molecular insights.
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.). Caris President David Spetzler, MS, PhD, MBA, added, "The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies."
