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Next Generation Sequencing for the Detection of Actionable Mutations in Solid and Liquid Tumors
Published on: September 20, 2016
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Insights of Clinical Significance From 109 695 Solid Tumor Tissue-Based Comprehensive Genomic Profiles
Andreas M Heilmann1, Jonathan W Riess2, Margaret McLaughlin-Drubin1
1Foundation Medicine, Cambridge, MA, USA.
The Oncologist
|September 8, 2023
Summary
FoundationOneCDx tumor profiling identified clinically significant genomic alterations in about half of patients with solid tumors. These findings offer valuable insights for cancer treatment decisions and clinical trial eligibility.
Area of Science:
- Genomic medicine
- Oncology
- Molecular diagnostics
Background:
- FoundationOneCDx is an approved companion diagnostic test in the US and Japan.
- It identifies patients eligible for 30 (US) and 23 (Japan) drug therapies.
- Beyond companion diagnostics, it detects clinically significant genomic findings for broader care decisions.
Purpose of the Study:
- To report the breadth and impact of clinical decision insights from FoundationOneCDx solid tumor profiles.
- To analyze the utility of comprehensive genomic profiling in routine clinical care.
Main Methods:
- Retrospective analysis of 109,695 consecutive FoundationOneCDx solid tumor test reports.
- Identification of clinically significant predictive, prognostic, and diagnostic genomic alterations and signatures.
- Matching tumor profiles to interventional clinical trials based on actionable, investigational, or hypothetical targets.
Main Results:
- Clinically significant predictive, prognostic, and diagnostic markers were reported in 51.2% of all tumor profiles.
- Pan-cancer predictive markers like high tumor mutational burden (TMB) and microsatellite instability (MSI) were observed.
- 89.2% of profiles had genomic results potentially informing immunotherapy and targeted therapy clinical trial selection.
Conclusions:
- Approximately half of patients with solid tumor profiles showed clinically significant genomic findings.
- FoundationOneCDx provides valuable genomic insights for real-world cancer patient care.
- These findings support the use of comprehensive genomic profiling in routine oncology practice.
