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

Matteo Allegretti; Alessandra Fabi; Simonetta Buglioni; Aline Martayan; Laura Conti; Edoardo Pescarmona; Gennaro Ciliberto; Patrizio Giacomini

doi:10.1186/s13046-018-0702-x

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

Matteo Allegretti, Alessandra Fabi, Simonetta Buglioni, Aline Martayan, Laura Conti, Edoardo Pescarmona, Gennaro Ciliberto, Patrizio Giacomini

Istituto Regina Elena

Research output: Contribution to journal › Review article › peer-review

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.

Original language	English
Article number	47
Journal	Journal of Experimental and Clinical Cancer Research
Volume	37
Issue number	1
DOIs	https://doi.org/10.1186/s13046-018-0702-x
Publication status	Published - Mar 5 2018

Keywords

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

ASJC Scopus subject areas

Oncology
Cancer Research

Access to Document

10.1186/s13046-018-0702-x

Fingerprint Dive into the research topics of 'Tearing down the walls: FDA approves next generation sequencing (NGS) assays for actionable cancer genomic aberrations'. Together they form a unique fingerprint.

Cite this

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.

In: Journal of Experimental and Clinical Cancer Research, Vol. 37, No. 1, 47, 05.03.2018.

Research output: Contribution to journal › Review article › peer-review

@article{6137f86889d54e868e297c06a42a8d9e,

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

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.",

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

author = "Matteo Allegretti and Alessandra Fabi and Simonetta Buglioni and Aline Martayan and Laura Conti and Edoardo Pescarmona and Gennaro Ciliberto and Patrizio Giacomini",

year = "2018",

month = mar,

day = "5",

doi = "10.1186/s13046-018-0702-x",

language = "English",

volume = "37",

journal = "Journal of Experimental and Clinical Cancer Research",

issn = "0392-9078",

publisher = "BioMed Central Ltd.",

number = "1",

}

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 -