The Center for Medical Technology Policy's Green Park Collaborative has embarked on a project to develop guidelines for generating evidence for the clinical utility of next-gen sequencing-based cancer diagnostics.

Over the next year or so, GPC, in collaboration with a broad array of stakeholders, plans to develop a so-called Effectiveness Guidance Document with recommendations for how to design studies to gather evidence of clinical utility. The goal is to help payors make coverage and reimbursement decisions for NGS-based diagnostic oncology tests.