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Updated: Feb 7, 2026

Next Generation Sequencing for the Detection of Actionable Mutations in Solid and Liquid Tumors
Published on: September 20, 2016
Tearing down the walls: FDA approves next generation sequencing (NGS) assays for actionable cancer genomic
Matteo Allegretti1,2, Alessandra Fabi2,3, Simonetta Buglioni2,4
1Oncogenomics and Epigenetics, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
Abstract:
The United States Food and Drug Administration (FDA) recently approved the clinical use of two comprehensive 'mid-size' Next Generation Sequencing (NGS) panels calling actionable genomic aberrations in cancer. This is the first endorsement, by a regulatory body, of a new standard of care in oncology. Herein, we argue that besides its many practice-changing implications, this approval tears down the conceptual walls dividing system biology from clinical practice, diagnosis from research, prevention from therapy, cancer genetics from cancer genomics, and computational biology from empirical therapy assignment.
Insights
The US FDA approved Next Generation Sequencing (NGS) panels for cancer care, marking a new standard. This advances precision oncology by integrating diverse biological and clinical fields.
Area of Science:
- Oncology
- Genomics
- Bioinformatics
Background:
- The US Food and Drug Administration (FDA) approved two Next Generation Sequencing (NGS) panels for clinical use.
- These panels identify actionable genomic aberrations in cancer patients.
- This marks the first regulatory endorsement of NGS as a standard of care in oncology.
Discussion:
- The approval signifies a paradigm shift in cancer diagnostics and treatment.
- It bridges the gap between system biology and clinical practice.
- It integrates research, diagnosis, prevention, and therapy in oncology.
Key Insights:
- NGS panel approval facilitates precision medicine by identifying specific genetic mutations.
- This regulatory milestone integrates computational biology with empirical therapy assignment.
- The approval breaks down conceptual silos in cancer research and clinical application.
Outlook:
- This advancement is expected to accelerate the adoption of genomic profiling in routine cancer care.
- It paves the way for more personalized and effective cancer treatments.
- Future research will likely focus on expanding the utility of NGS in diverse cancer types and patient populations.
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