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Genomics

Robust technical proficiency in genomics for retrospective and prospective biomaker analysis.

ICON utilises robust technical proficiency in genomics, including NGS, ddPCR, and qPCR, along with over ten years of experience in developing and validating clinical trial assays, to meet sponsors' needs for both retrospective and prospective biomarker analysis in clinical trials. 

Delivering value for your clinical trial:

 

  • Extensive expertise in genomic assay design, validation, and bioinformatics.
  • Thorough validation processes to assess product strengths and weaknesses, enhancing assay performance through additional data analysis beyond commercial software capabilities
  • A wide range of commercially validated assays ready for immediate use in clinical trials
  • Development and validation of assays tailored to sponsors' specific needs 
  • Proven success in custom assay development, securing approvals from regulatory bodies such as NY state, FDA IDE, and PMA.
  • High-quality deliverables with fast turnaround times.
  • Flexibility, agility, and strong collaboration with clients

For Next Generation Sequencing, ICON leverages variable library prep methods and Illumina and ThermoFisher sequencing platforms to address sponsor’s need in comprehensive or focused biomarker analysis.

 

NGS platforms

  • Illumina: MiSeqDx/MiSeq, NextSeq550Dx, NovaSeq6000Dx

  • ThermoFisher: Genestudio S5xl, Genexus

     

Library prep chemistry

  • Probe capture
  • Anchored Multiplex PCR (ArcheDx)
  • AmpliSeq (ThermoFisher)

  • Long-range PCR and NexteraXT

     

Data analysis

  • Commercial NGS software: local and cloud
  • Custom NGS analysis pipeline
  • Thorough data review by two independent experienced data scientists via IGV review
  • Raw data including fastq, BAM, vcf can be shared with sponsor by sFTP, or Amazon s3 bucket

Selective assays

 

Comprehensive genomic profiling

  • Illumina TruSight Oncology 500 Panel: for solid tumor and CHiP mutation
  • Illumina TruSight Oncology 500 ctDNA v2 Panel: for liquid biopsy

  • Illumina TruSeq RNA exome: gene expression and fusion

     

Focused targeted panels

  • ArcherDx Core Myeloid Panel (37 genes) and Myeloid Panel (75 genes)*: myeloid cancer and CHiP mutation
  • ArcherDx Solid Tumor VariantPlex Panel*: solid tumor
  • ArcherDx Solid Tumor FusionPlex Panel*: solid tumor
  • ThermoFisher Oncomine Comprehensive Assay v3: solid tumor

  • ThermoFisher Oncomine cfDNA Panel: for liquid biopsy

     

Custom NGS assay

  • BCR:ABL1 NGS: for CML
  • Add-on genes on the existing Archer panels
  • TwinStrand custom assay for high sensitivity mutation detection in MRD
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