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

打破壁垒:FDA批准下一代测序(NGS)检测可用于检测癌症基因组异常

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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.

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