REGULATORY

REGULATORY

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

REIMBURSEMENT

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

INTELLECTUAL PROPERTY

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

Letter to the National Government Services Medical Policy Unit Regarding the Proposed Local Coverage Determination — Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to submit comments regarding the above-captioned proposed Local Coverage Determination (LCD).

…C21 member companies currently offer and/or are actively developing next generation sequencing (NGS)-based comprehensive genomic profiles (CGPs) for patients with advanced cancer. Given C21’s mission to facilitate the development and commercialization of innovative diagnostics, C21 has a keen interest in National Government Services’ consideration of the above-captioned proposed LCD.

C21 strongly supports the proposed LCD insofar as it would expand coverage for NGS-based CGPs offered as laboratory-developed tests (LDTs), as permitted under National Coverage Determination (NCD) 90.2.

Welcome from the Coalition Steering Committee

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, Chairman of the Board and CEO, Veracycte

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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