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Published on: April 11, 2016
11.9K
Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors
Coren A Milbury1, James Creeden2, Wai-Ki Yip1
1Department Product Development, Cambridge, MA, United States of America.
Plos One
|March 16, 2022
Summary
FoundationOne®CDx (F1CDx) is an FDA-approved test using comprehensive genomic profiling to identify cancer gene alterations. Extensive validation ensures its reliability for precision medicine, matching patients with targeted therapies.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Precision medicine relies on accurate genomic profiling for targeted cancer therapies.
- Comprehensive genomic profiling (CGP) analyzes multiple cancer genes simultaneously.
- Biomarker testing complexity necessitates validated and reliable diagnostic tools.
Purpose of the Study:
- To present the analytical and clinical validation supporting FoundationOne®CDx (F1CDx) FDA approvals.
- To demonstrate the reliability, accuracy, and clinical utility of F1CDx for solid tumor patients.
- To highlight F1CDx's role in advancing precision oncology.
Main Methods:
- Utilized next-generation sequencing (NGS) for comprehensive genomic profiling (CGP) of 324 cancer genes.
- Conducted extensive analytical validation, including limit of detection, precision, and concordance studies.
- Analyzed over 30,000 test results to support clinical utility and assay performance.
Main Results:
- Demonstrated high sensitivity, specificity, and reliability of F1CDx for detecting various genomic alterations.
- Confirmed F1CDx's capability to report short variants, copy number alterations, rearrangements, TMB, MSI, and gLOH.
- Established a substantial body of evidence supporting F1CDx's clinical utility in matching patients to therapies.
Conclusions:
- F1CDx provides a validated and reliable CGP solution for precision oncology.
- The test meets clinical needs for guideline-based biomarker testing in a rapidly evolving field.
- F1CDx facilitates informed treatment decisions, improving outcomes for cancer patients.
