A roundtable discussion among leading government, industry, and academic experts to explore innovative solutions to current regulatory and reimbursement barriers for molecular and other diagnostics. The objective was to discuss the practical implementation of parallel review and coverage with evidence development as mechanisms to advance the evaluation and clinical use of these technologies. A discussion paper prepared for workshop attendees is attached here. A white paper authored by some of the workshop attendees has been published in the journal Science & Translational Medicine and can be downloaded at the link below.
George Poste, Biomarker and Molecular Diagnostics Landscape
Mollie Roth / Regulatory and Reimbursement Challenges / Introduction of CED and Parallel Review
Denis Cortese / Workshop Overview and Closing Remarks