4.7 Editorial Material

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

Journal

Publisher

BIOMED CENTRAL LTD
DOI: 10.1186/s13046-018-0702-x

Keywords

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

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Funding

  1. Associazione Italiana per la Ricerca sul Cancro (AIRC Nuvenia Fellowship) [19503, 14204, 19052]
  2. EU project ULTRAPLACAD [633937]
  3. Regina Elena Scientific Direction

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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.

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