Grace K Dy, Mary K Nesline, Antonios Papanicolau-Sengos, Paul DePietro, Charles M LeVea, Amy Early, Hongbin Chen, Anne Grand'Maison, Patrick Boland, Marc S Ernstoff, Stephen Edge, Stacey Akers, Mateusz Opyrchal, Gurkamal Chatta, Kunle Odunsi, Sarabjot Pabla, Jeffrey M Conroy, Sean T Glenn, Hanchun T DeFedericis, Blake Burgher, Jonathan Andreas, Vincent Giamo, Maochun Qin, Yirong Wang, Kazunori Kanehira, Felicia L Lenzo, Peter Frederick, Shashikant Lele, Lorenzo Galluzzi, Boris Kuvshinoff, Carl Morrison
BACKGROUND: Regulatory approval of next generation sequencing (NGS) by the FDA is advancing the use of genomic-based precision medicine for the therapeutic management of cancer as standard care. Recent FDA guidance for the classification of genomic variants based on clinical evidence to aid clinicians in understanding the actionability of identified variants provided by comprehensive NGS panels has also been set forth. In this retrospective analysis, we interpreted and applied the FDA variant classification guidance to comprehensive NGS testing performed for advanced cancer patients and assessed oncologist agreement with NGS test treatment recommendations...
January 18, 2019: BMC Medical Informatics and Decision Making