Paul F. Engstrom1, Mara G. Bloom2, George D. Demetri3, Phillip G. Febbo4, William Goeckeler5, Marc Ladanyi6, Bryan A. Loy7, Kate Murphy8, Michael Nerenberg9, Paul Papagni10, Mark E. Robson6, Robert Sweetman11, Sean Tunis12, Jessica K. DeMartino, Jonathan K. Larsen
1Fox Chase Cancer Center
2Harvard University
3Dana Farber Cancer Institute
4UCSF Helen Diller Family Comprehensive Cancer Center
5#N##TAB##TAB##TAB##TAB# Boehringer Ingelheim Pharmaceuticals Inc#N##TAB##TAB##TAB#
6Memorial Sloan- Kettering Cancer Center
7Humana
8Colorectal Cancer Coalition
9Genoptix
10University of Texas MD Anderson Cancer Center
11Pfizer
12Center for Medical Technology Policy
Tóm tắt
Personalized medicine in oncology is maturing and evolving rapidly, and the use of molecular biomarkers in clinical decision-making is growing. This raises important issues regarding the safe, effective, and efficient deployment of molecular tests to guide appropriate care, specifically regarding laboratory-developed tests and companion diagnostics. In May 2011, NCCN assembled a work group composed of thought leaders from NCCN Member Institutions and other organizations to identify challenges and provide guidance regarding molecular testing in oncology and its corresponding utility from clinical, scientific, and coverage policy standpoints. The NCCN Molecular Testing Work Group identified challenges surrounding molecular testing, including health care provider knowledge, determining clinical utility, coding and billing for molecular tests, maintaining clinical and analytic validity of molecular tests, efficient use of specimens, and building clinical evidence.
