Open AccessWeighing the Evidence: Variant Classification and Interpretation in Precision Oncology, US Food and Drug Administration Public Workshop—Workshop Proceedings
Author(s) -
Hisani N. Horne,
Donna Roscoe,
E. David Litwack,
Anand Pathak,
Jai Prakash Pandey,
Pamela Gallagher,
Laura M. Koontz,
Robert N. Schuck,
Eunice Lee,
Hu Yun,
Julia A. Beaver,
Gideon M. Blumenthal,
Reena Philip
Publication year - 2019
Publication title -
jco precision oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.405
H-Index - 22
ISSN - 2473-4284
DOI - 10.1200/po.18.00314
Subject(s) - standardization , oncology , precision medicine , food and drug administration , medicine , best practice , government (linguistics) , interpretation (philosophy) , medical education , computer science , political science , pharmacology , pathology , law , programming language , linguistics , philosophy , operating system
Next-generation sequencing (NGS) oncology panels are becoming integral in hospital and academic settings to guide patient treatment and enrollment in clinical trials. Although NGS technologies have revolutionized decision-making for cancer therapeutics, physicians may face many challenges in parsing and prioritizing NGS-based test results to determine the best course of treatment for individual patients. On January 29, 2018, the US Food and Drug Administration held a public workshop entitled, "Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology." Here, we discuss the presentations and discussion highlights across the four sessions of the workshop.