FDA Approves MI Cancer Seek as Companion Diagnostic for Targeted Therapy Across Tumor Types
核心洞察
The FDA has approved MI Cancer Seek as a companion diagnostic to identify cancer patients who may benefit from targeted therapy, covering both adult and pediatric populations.
MI Cancer Seek is the first FDA-approved assay that combines whole-exome sequencing (WES) and whole-transcriptome sequencing (WTS) for molecular profiling of solid tumors.
The diagnostic can detect single nucleotide variants, insertions, deletions, microsatellite instability (MSI), and tumor mutational burden (TMB) across multiple cancer types.
The FDA has granted approval to MI Cancer Seek as a companion diagnostic, facilitating the identification of cancer patients, including those aged 1 to 22, who could benefit from targeted therapy. This diagnostic tool encompasses one pan-tumor and five tumor-specific indications for several FDA-approved therapies.
MI Cancer Seek stands out as the first and only assay approved by the FDA that simultaneously utilizes whole-exome sequencing (WES) and whole-transcriptome sequencing (WTS). This combination allows for comprehensive molecular profiling of solid tumors. By integrating WES and WTS into a single workflow, MI Cancer Seek conserves tissue samples without sacrificing the breadth of results. Traditional DNA and RNA analysis via next-generation sequencing (NGS) often require two separate testing processes, demanding more tissue and time.
Comprehensive Molecular Profiling
MI Cancer Seek is an NGS-based in vitro diagnostic that uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens. The diagnostic employs this technology to detect single nucleotide variants, insertions, and deletions across 228 genes. Additionally, it can detect microsatellite instability (MSI) and tumor mutational burden in patients with previously diagnosed solid tumors, as well as copy number amplification in a single gene in breast cancer (搜索) patients.
Companion Diagnostic Indications
MI Cancer Seek now has companion diagnostic indications for breast cancer (搜索), colorectal cancer (搜索) (CRC), melanoma (搜索), non-small cell lung cancer (搜索) (NSCLC), endometrial carcinoma (搜索), and solid tumors. In breast cancer, it detects PIK3CA alterations (C420R; E542K; E545A, E545D [1635G > T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) to determine eligibility for alpelisib (Piqray) treatment. For CRC, MI Cancer Seek identifies KRAS (搜索) and NRAS (搜索) wild-type biomarkers for panitumumab (Vectibix) treatment, and BRAF (搜索) V600E for encorafenib (Braftovi) combined with cetuximab (Erbitux).
In melanoma (搜索), MI Cancer Seek detects BRAF (搜索) V600E for BRAF inhibitors and BRAF V600E or V600K for trametinib (Mekinist) or BRAF/MEK inhibitor combinations. In NSCLC, it identifies EGFR (搜索) exon 19 deletions and exon 21 L858R alterations for EGFR TKIs. For endometrial carcinoma (搜索), MI Cancer Seek identifies patients who are not MSI high for pembrolizumab (Keytruda) combined with lenvatinib (Lenvima). It also identifies patients with MSI-high solid tumors for pembrolizumab and/or dostarlimab-gxly (Jemperli) treatment.
David Dean Halbert, DSc (h.c.), chairman, founder, and CEO of Caris Life Sciences (搜索), stated, “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. We are thrilled to bring MI Cancer Seek to market to ensure patients have access to critical precision medicine tools.”
David Spetzler, MS, PhD, MBA, president of Caris Life Sciences (搜索), 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. The process of working with the FDA was both collaborative and insightful, and we applaud their expertise in the evaluation of novel technologies.”