TY - JOUR
T1 - Tearing down the walls
T2 - FDA approves next generation sequencing (NGS) assays for actionable cancer genomic aberrations
AU - Allegretti, Matteo
AU - Fabi, Alessandra
AU - Buglioni, Simonetta
AU - Martayan, Aline
AU - Conti, Laura
AU - Pescarmona, Edoardo
AU - Ciliberto, Gennaro
AU - Giacomini, Patrizio
PY - 2018/3/5
Y1 - 2018/3/5
N2 - 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.
AB - 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.
KW - Bioinformatics
KW - Cancer screening and prevention
KW - Ethics
KW - Genomic aberrations
KW - Next generation sequencing (NGS)
KW - Patient advocacy
KW - Precision medicine
KW - Regulatory issues
UR - http://www.scopus.com/inward/record.url?scp=85042907219&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85042907219&partnerID=8YFLogxK
U2 - 10.1186/s13046-018-0702-x
DO - 10.1186/s13046-018-0702-x
M3 - Review article
AN - SCOPUS:85042907219
VL - 37
JO - Journal of Experimental and Clinical Cancer Research
JF - Journal of Experimental and Clinical Cancer Research
SN - 0392-9078
IS - 1
M1 - 47
ER -