Encouraging the Research, Development and Commercialization of Innovative New Technologies

Our Mission

To improve the quality of healthcare by encouraging research, development and commercialization of innovative diagnostic technologies that will personalize patient care, improve patient outcomes and substantially reduce healthcare costs.

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

Development of and access to innovative molecular diagnostics is essential to enabling individualized treatment and has the potential to revolutionize our healthcare system. However, the potential for advanced diagnostics to help patients has yet to be fully realized, due in large part to the widespread perception by many companies/investors that the costs, risks and barriers associated with diagnostic development outweigh the anticipated returns. Advances in technology and genomic information are rapidly changing the commercial diagnostic landscape and opening up new opportunities for advanced diagnostic tests. Government policies will play a crucial role in diagnostic innovation and have the potential either to slow such innovation or to help lower diagnostic development risks/barriers.

Ensuring Diagnostics Innovation and Availability

The Coalition for 21st Century Medicine represents more than two dozen of the world’s most renowned diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists and patient advocacy groups. We’re working to ensure that high quality, innovative diagnostic tests—necessary to assure that timely and accurate information is available when diagnosis, prognosis and therapy decisions need to be made—are available to patients and their physicians. To that end, we’re working with policymakers to maintain the balance between regulation and innovation and to ensure that regulatory policy promotes rapid access to new diagnostic information.

Achieving Our Goals—Today and Tomorrow

Founded in 2006, the Coalition began with two specific goals:

• To work with the FDA to revise the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) and the Analyte Specific Reagent (ASR) guidance documents in a manner that would secure a regulatory environment that supports and sustains innovation in the development of molecular diagnostics and personalized medicine
• To work with Congress and via other means to expand patient, public and policymaker understanding of the importance and promise of innovative molecular diagnostics and personalized medicine in the detection, treatment and cure of diseases

We continue to advocate for advanced diagnostic testing through various means—visit our Coalition Agenda page for an overview of past successes and current initiatives.