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

Allegretti M1,2, Fabi A2,3, Buglioni S2,4, Martayan A2,5, Conti L2,5,6, Pescarmona E2,4,6, Ciliberto G2,7, Giacomini P8,9.

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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.

KEYWORDS:

Bioinformatics; Cancer screening and prevention; Ethics; Genomic aberrations; Next generation sequencing (NGS); Patient advocacy; Precision medicine; Regulatory issues