Molecular Diagnostics Workshop / April 4, 2012

Gary Marchant
Workshop Co-Organizer

Rachel Lindor
Workshop Co-Organizer

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.

Potential Solutions to Regulatory and Reimbursement Barriers for Molecular Diagnostics: Parallel Review and Coverage with Evidence Development 

 Agenda

Presentations:

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

Read Paper:

Regulatory and Reimbursement Innovation, published in Science Translation Medicine, March 13, 2013.