Revolutionising Oncology Trials with NGS Support for Patient Stratification

Save time and cost while increasing the probability of success.

At Intertek Pharmaceutical Services we use the power of specific next generation sequencing platforms to enable us to provide compliant, high-throughput NGS services tailored to clinical trial needs. This first-in-market capability positions us as a strategic partner for precision medicine and biomarker-driven trials. 

Tumour Heterogeneity Challenge

  • Cancers contain multiple mutations and subclonal populations
  • Common actionable mutations: EGFR, KRAS, BRAF, PIK3CA, BRCA1/2, TP53, ALK, NTRK1/2/3
  • Includes complex biomarkers such as MSI

The Next Generation Sequencing Advantage for Oncology Clinical Trials

  • Broad panels capture hundreds of targets in a single test
  • Simultaneous detection of SNVs, indels, CNVs, and gene fusions
  • Includes DNA and RNA-based alterations

NGS Time-Saving Impact

  • Patient screen-fail rate reduced from 30-50% to 10-20%
  • Time to enrol patients reduced from months to just a few weeks
  • <1 week turnaround time from sample to result

NGS Cost-Saving Impact

  • Up to 25-30% reduction in patient costs for Phase I/II trials by reducing failures
  • Screen-fail repeats reduced by 50-70% via pre-screened eligible pool
  • Avoid significant costs by mitigating delays in CRO, staffing, and site operations

Strategic Benefits of Early Genomic Screening

  • Patient Matching Pre-CTA Approval: Build a ready-to-enrol cohort through non-interventional studies
  • Data-Driven Site Selection: Prioritize sites with enriched mutation positive patients
  • Fewer Amendments, Better Design: Refine trial criteria before formal trial design
  • Regulatory Readiness: IVD-regulated stratification supports regulatory submission endpoints

Contact our team today to learn how Intertek’s next generation sequencing capabilities deliver measurable impact across oncology clinical development:

Contact Intertek