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

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...

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Detalles Bibliográficos
Autores principales: Allegretti, Matteo, Fabi, Alessandra, Buglioni, Simonetta, Martayan, Aline, Conti, Laura, Pescarmona, Edoardo, Ciliberto, Gennaro, Giacomini, Patrizio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838869/
https://www.ncbi.nlm.nih.gov/pubmed/29506529
http://dx.doi.org/10.1186/s13046-018-0702-x
Descripción
Sumario: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.