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Next Generation Sequencing for the Detection of Actionable Mutations in Solid and Liquid Tumors
Published on: September 20, 2016
Clinical Utilization, Utility, and Reimbursement for Expanded Genomic Panel Testing in Adult Oncology
Susan J Hsiao1, Anthony N Sireci1, Danielle Pendrick1
1Department of Pathology and Cell Biology, Columbia University Irving Medical Center, New York, NY.
Purpose:
The routine use of large next-generation sequencing (NGS) pan-cancer panels is required to identify the increasing number of, but often uncommon, actionable alterations to guide therapy. Inconsistent coverage and variable payment is hindering NGS adoption into clinical practice. A review of test utilization, clinical utility, coverage, and reimbursement was conducted in a cohort of patients diagnosed with high-risk cancer who received pan-cancer panel testing as part of their clinical care.
Materials And Methods:
The Columbia Combined Cancer Panel (CCCP), a 467-gene panel designed to detect DNA variations in solid and liquid tumors, was performed in the Laboratory of Personalized Genomic Medicine at Columbia University Irving Medical Center. Utilization was characterized at test order. Results were reviewed by a molecular pathologist, followed by a multidisciplinary molecular tumor board where clinical utility was classified by consensus. Reimbursement was reviewed after payers provided final coverage decisions.
Results:
NGS was performed on 359 high-risk tumors from 349 patients. Reimbursement data were available for 246 cases. The most common reason providers ordered CCCP testing was for patients diagnosed with a treatment-resistant or recurrent tumor (n = 214; 61%). Findings were clinically impactful for 229 cases (64%). Molecular alterations that may inform future therapy in the event of progression or relapse were found in 42% of cases, and a targeted therapy was initiated in 23 cases (6.6%). The majority of tests were denied coverage by payers (n = 190; 77%). On average, insurers reimbursed 10.75% of the total NGS service charge.
Conclusion:
CCCP testing identified clinically impactful alterations in 64% of cases. Limited coverage and low reimbursement remain barriers, and broader reimbursement policies are needed to adopt pan-cancer NGS testing that benefits patients into clinical practice.
Insights
Next-generation sequencing (NGS) pan-cancer panels identify actionable alterations in 64% of high-risk cancer patients. However, limited insurance coverage and low reimbursement hinder widespread clinical adoption of this vital genomic testing.
Area of Science:
- Genomic Medicine
- Oncology
- Molecular Diagnostics
Background:
- Next-generation sequencing (NGS) pan-cancer panels are crucial for identifying rare, actionable genetic alterations to guide cancer therapy.
- Clinical adoption of NGS testing is impeded by inconsistent insurance coverage and variable reimbursement policies.
- This study reviews the utilization, clinical utility, coverage, and reimbursement of a comprehensive NGS pan-cancer panel in high-risk cancer patients.
Purpose of the Study:
- To evaluate the clinical utility and economic viability of a large-gene next-generation sequencing (NGS) pan-cancer panel in a real-world clinical setting.
- To assess test utilization patterns, identify clinically impactful findings, and analyze coverage and reimbursement rates for NGS testing in high-risk cancer patients.
Main Methods:
- The Columbia Combined Cancer Panel (CCCP), a 467-gene NGS panel, was performed on 359 high-risk tumors from 349 patients.
- Test utilization was tracked, and clinical utility was determined by a multidisciplinary molecular tumor board.
- Reimbursement data were analyzed following final payer coverage decisions.
Main Results:
- Clinically impactful alterations were identified in 64% of cases, with 42% revealing alterations for potential future therapy.
- Targeted therapy was initiated in 6.6% of patients.
- A significant majority of tests (77%) were denied coverage by payers, with an average reimbursement of only 10.75% of the service charge.
Conclusions:
- The CCCP identified clinically significant genomic alterations in a majority of high-risk cancer patients, demonstrating its utility.
- Limited insurance coverage and inadequate reimbursement represent substantial barriers to the routine clinical implementation of pan-cancer NGS panels.
- Broader reimbursement policies are essential to facilitate the adoption of beneficial NGS testing for improved patient care.
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