The Regulatory Workgroup engages with stakeholders to discuss the appropriate regulatory framework for advanced diagnostic tests... Read More »


The Reimbursement Workgroup is playing a lead role in crafting the future of coding, coverage, and payment for ADLTs... Read More »


The Intellectual Property Workgroup is deeply committed to advocacy for protection of intellectual property rights for innovators... Read More »

Advanced Diagnostics Are Key to the Future of Quality, Affordable Healthcare

The Coalition for 21st Century Medicine represents some of the world’s most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups – all linked by a common mission to develop and make available state-of-the-art diagnostics that improve patient health.

Latest Position Statement

Supplemental Responses to Questions Raised by the Advisory Panel on Clinical Diagnostic Laboratory Tests at September 12, 2016 Meeting

On behalf of the Coalition for 21st Century Medicine (C21), we appreciated the opportunity to present our recommendations regarding the application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs) to the Advisory Panel on Clinical Diagnostic Laboratory Tests at its September 12, 2016 meeting. As a follow up to the Advisory Panel meeting, we would like to provide supplemental responses to several of the questions raised by the Panel. As CMS prepares the sub-regulatory guidance for the ADLT application and designation process, we believe it is important to implement the ADLT payment category in a way that promotes continued competition and innovation in precision medicine.

Welcome from the Coalition Steering Committee

Kim Popovits“The value of molecular diagnostics in delivering precision medicine in healthcare is simply way too high to ignore. Genomic medicine should and will be the future. In our efforts to help more patients improve their health outcomes, we must develop a framework for regulatory and reimbursement pathways that inspires innovation and investment in this important field.” – Kim Popovits, President and CEO, Genomic Health

Join the Coalition

US CapitolNever has your membership in the Coalition been more important than it is now, as we look forward to enacting the most significant health-related legislation of the decade and stand on the cusp of a revolution in the delivery of personalized health care. Join Now ยป

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  • Genomic Health
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