Cancer Genomics & Oncology: Precision Tumor Profiling & Clinical Impact

White Paper October 2025 Authors: Dr. Priya Nair, Dr. Alex Kim, Dr. Lisa Wang

Comprehensive clinical validation of a cancer genomics platform for tumor profiling, liquid biopsy, and precision oncology applications. This white paper details the methodology, results, and clinical impact of advanced genomics in oncology.

Executive Summary

  • 20+ cancer types profiled (solid & hematologic)
  • 92% concordance with tissue biopsy for liquid biopsy
  • 1,200+ actionable mutations detected
  • 50+ precision oncology clinical trials enabled
20+
Cancer Types
92%
Liquid Biopsy Concordance
1,200+
Actionable Mutations
50+
Clinical Trials

Methodology

  1. Sample Collection: Tumor tissue and blood samples from 2,000+ patients across 20 cancer types.
  2. Sequencing: Hybrid-capture NGS panel (500+ genes), WES, and RNA-seq for transcriptome profiling.
  3. Bioinformatics: AI-driven variant calling, fusion detection, and copy number analysis.
  4. Clinical Annotation: Actionability assessment using OncoKB, CIViC, and clinical trial databases.
Cancer Genomics Workflow

Figure: End-to-end workflow for cancer genomics profiling and clinical reporting.

Results & Clinical Impact

  • High Sensitivity & Specificity: 98% sensitivity and 97% specificity for key driver mutations (EGFR, KRAS, BRAF, TP53, etc.).
  • Liquid Biopsy Validation: 92% concordance with matched tissue biopsy in 500+ cases.
  • Actionable Findings: 1,200+ actionable mutations linked to FDA/EMA-approved therapies and clinical trials.
  • Clinical Trials: Enabled patient enrollment in 50+ precision oncology trials.
  • Turnaround Time: Median 7 days from sample receipt to report.

Conclusions

Cancer genomics platforms are transforming oncology by enabling comprehensive tumor profiling, non-invasive liquid biopsy, and precision therapy selection. Clinical validation demonstrates robust performance, high concordance, and significant impact on patient care and clinical research.

References

  1. Schwartzberg L, et al. "Precision Oncology: Integrating Genomics into Cancer Care." JCO Oncol Pract. 2022.
  2. Meric-Bernstam F, et al. "Clinical Impact of Comprehensive Genomic Profiling in Cancer." Nat Rev Clin Oncol. 2023.
  3. FDA. "Liquid Biopsy in Oncology Drug and Device Development." Guidance for Industry. 2024.