Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome sequencing-based comprehensive molecular profiling assay (IMAGE)
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Figure 1: Overview of MI Cancer Seek workflow. MI Cancer Seek begins with total nucleic acid (TNA) extraction from formalin-fixed, paraffin-embedded (FFPE) tissue slides. A minimum 20% tumor content and 25 mm2 is required, which is obtained through manual microdissection if required. During library preparation, RNA is labeled during first strand cDNA synthesis. Sequencing is performed on qualified Illumina NovaSeq 6000 instruments. Raw data is processed by Caris’ proprietary bioinformatics pipeline, and a report is generated that includes CDx biomarkers (level 1 evidence), clinically relevant biomarkers (level 2 evidence), and biomarkers with possible clinical significance (level 3 evidence). Abbreviations: CNV: copy number variation; EBV: Epstein-Barr virus; GPS: genomic probability score; HLA: human leukocyte antigen; HPV: human papilloma virus; HRD: homologous recombination deficiency; INDEL: insertion/deletion; LoH: loss of heterozygosity; MCPyV: Merkel cell polyomavirus; MSI: microsatellite instability; SNV: single nucleotide variant; TMB: tumor mutational burden. Created in BioRender. Ribeiro, J. (2025) https://BioRender.com/m29z318.
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Copyright: © 2025 Domenyuk et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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