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

Area of Science:

• Oncology
• Genomics
• Molecular Diagnostics

Background:

• Advances in next-generation sequencing (NGS) enhance understanding of cancer biology and treatment response.
• The National Comprehensive Cancer Network (NCCN) aims to assess the current state of molecular profiling/diagnostic testing at its member institutions and affiliated sites.

Purpose of the Study:

• To gather baseline information on the utilization of cancer-related molecular testing.
• To identify barriers and facilitators to the integration of molecular profiling into patient care.

Main Methods:

• Two surveys were distributed in December 2013 and September 2014 to NCCN Member Institutions and community members of the NCCN Affiliate Research Consortium.
• Molecular profiling/diagnostics were defined as a panel of at least 10 genes tested in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Main Results:

• Data were collected from 24 NCCN Member Institutions and 8 affiliate sites.
• Molecular profiling/diagnostics are employed in 100% of responding institutions for patient care decisions.
• Key challenges identified include reimbursement issues, insufficient data on actionable targets and therapies, and drug access for clinical trials.

Conclusions:

• Frameworks for interpreting molecular diagnostic results based on evidence levels are recommended.
• Further research into biomarker predictive value and targeted therapies is crucial.
• Establishing clinical and cost-effectiveness evidence is essential for broader insurance coverage and integration into patient care.