Tearing down the walls: FDA approves next generation sequencing (NGS) assays for actionable cancer genomic aberrations

Tearing down the walls: FDA approves next generation sequencing (NGS) assays for actionable cancer genomic aberrations

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...

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Bibliographic Details
Main Authors: Matteo Allegretti, Alessandra Fabi, Simonetta Buglioni, Aline Martayan, Laura Conti, Edoardo Pescarmona, Gennaro Ciliberto, Patrizio Giacomini
Format: Article
Language:English
Published: BMC 2018-03-01
Series:Journal of Experimental & Clinical Cancer Research
Subjects:
Next generation sequencing (NGS)
Precision medicine
Genomic aberrations
Regulatory issues
Ethics
Patient advocacy
Online Access:http://link.springer.com/article/10.1186/s13046-018-0702-x
Description
Summary: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.
ISSN:1756-9966

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