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 Press Release

Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Final Rule for Regulating Lab-Developed Tests as Medical Devices

The Food and Drug Administration (FDA) announced on April 29, 2024 that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices. C21 has long been concerned that applying FDA regulatory requirements designed for distributed medical devices to laboratory procedures will hinder patient access to critical LDTs that are the leading edge of advancing precision medicine in patient care.

Welcome from the Board of Directors

Bonnie Anderson Headshot“Advanced genomic diagnostics are key to realizing the promise of Precision Medicine. By enabling smarter, more targeted and more personalized medicine, we can improve patient outcomes and reduce the use of healthcare resources. To achieve this potential, we must ensure regulatory, reimbursement and legal frameworks that recognize the value of our tests and encourage continued innovation and investment in this important field.” — Bonnie Anderson, Board Member and Co-Founder, Veracyte

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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