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Tearing down the walls: FDA approves next generation sequencing (NGS) assays for actionable cancer genomic aberrations.
Allegretti, Matteo; Fabi, Alessandra; Buglioni, Simonetta; Martayan, Aline; Conti, Laura; Pescarmona, Edoardo; Ciliberto, Gennaro; Giacomini, Patrizio.
Afiliação
  • Allegretti M; Oncogenomics and Epigenetics, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Fabi A; Regina Elena NGS group, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Buglioni S; Regina Elena NGS group, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Martayan A; Medical Oncology 1, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Conti L; Regina Elena NGS group, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Pescarmona E; Pathology, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Ciliberto G; Regina Elena NGS group, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
  • Giacomini P; Clinical Pathology, IRCSS Regina Elena National Cancer Institute, Rome, Italy.
J Exp Clin Cancer Res ; 37(1): 47, 2018 Mar 05.
Article em En | MEDLINE | ID: mdl-29506529
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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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Variação Genética / Testes Genéticos / Genômica / Aprovação de Teste para Diagnóstico / Sequenciamento de Nucleotídeos em Larga Escala / Neoplasias Tipo de estudo: Diagnostic_studies / Prognostic_studies / Screening_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Variação Genética / Testes Genéticos / Genômica / Aprovação de Teste para Diagnóstico / Sequenciamento de Nucleotídeos em Larga Escala / Neoplasias Tipo de estudo: Diagnostic_studies / Prognostic_studies / Screening_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2018 Tipo de documento: Article