NCCN Oncology Research Program's Investigator Steering Committee and NCCN Best Practices Committee Molecular Profiling Surveys

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  • a From UC San Diego Moores Cancer Center, San Diego, California; Stanford Cancer Institute, Stanford, California; Fox Chase Cancer Center, Philadelphia, Pennsylvania; Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah; Vanderbilt-Ingram Cancer Center, Nashville, Tennessee; The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, Columbus, Ohio; Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Washington University, St. Louis, Missouri; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland; City of Hope Comprehensive Cancer Center, Los Angeles, California; The West Clinic, Memphis, Tennessee; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California; Johns Hopkins University School of Medicine, Baltimore, Maryland; and Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance.
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Background: With advances such as next-generation sequencing (NGS) increasing understanding of the basis of cancer and its response to treatment, NCCN believes it is important to understand how molecular profiling/diagnostic testing is being performed and used at NCCN Member Institutions and their community affiliates. Methods: The NCCN Oncology Research Program's Investigator Steering Committee and the NCCN Best Practices Committee gathered baseline information on the use of cancer-related molecular testing at NCCN Member Institutions and community members of the NCCN Affiliate Research Consortium through 2 separate surveys distributed in December 2013 and September 2014, respectively. Results: A total of 24 NCCN Member Institutions and 8 affiliate sites provided quantitative and qualitative data. In the context of these surveys, “molecular profiling/diagnostics” was defined as a panel of at least 10 genes examined as a diagnostic DNA test in a Clinical Laboratory Improvement Amendments (CLIA)–certified laboratory. Conclusions: Results indicated that molecular profiling/diagnostics are used at 100% of survey respondents' institutions to make patient care decisions. However, challenges relating to reimbursement, lack of data regarding actionable targets and targeted therapies, and access to drugs on or off clinical trials were cited as barriers to integration of molecular profiling into patient care. Frameworks for using molecular diagnostic results based on levels of evidence, alongside continued research into the predictive value of biomarkers and targeted therapies, are recommended to advance understanding of the role of genomic biomarkers. Greater evidence and consensus regarding the clinical and cost-effectiveness of molecular profiling may lead to broader insurance coverage and increased integration into patient care.

Correspondence: Razelle Kurzrock, MD, UC San Diego Moores Cancer Center, 3855 Health Sciences Drive, MC #0658, La Jolla, California 92093-0658. E-mail: rkurzrock@ucsd.edu

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