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 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.

Fig. 1

Mid-size NGS gene panels vs conventional molecular diagnostics. These new companion assays introduce two major conceptual changes: (a) routine molecular diagnosis no longer focuses on single genes, but encompasses a comprehensive set of alterations, inspiring (b) multidisciplinary cancer treatment at outset, and progressively narrowing down indications for single-marker companion diagnostics