Policy Category: Science Policy

National Government Services’ Proposed Local Coverage Determination on Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

Proposed Changes to NCQA’s Colorectal Cancer Screening Measure

CMS’ Coverage of Next-Generation Sequencing-Based Diagnostic Tests

ICER’s Value Assessment Framework Methods and Procedures

A Consumer’s Guide to Genetic Health Testing

FDA’s Oversight of Development and Labeling for In Vitro Companion Diagnostic Devices in Oncology

FDA’s Oversight of Gene Therapies

Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps

European Medicines Agency’s 2017 Concept Paper on Predictive Biomarker-Based Assay Development

FDA’s Oversight of Next-Generation Sequencing-Based In Vitro Diagnostics