Our Mission
Our mission is to improve the quality of healthcare by encouraging the research, development and commercialization of innovative new diagnostic technologies.
The Coalition for 21st Century Medicine ("e;Coalition"e;) represents more than two dozen of the world?s most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups.
Coalition members share a belief and passion that the development of and access to innovative molecular diagnostics for patients is the foundation of personalized medicine, is essential to enable individualized treatment, and has the potential to revolutionize our healthcare system. Coalition members are linked by a common mission to develop advanced diagnostics that will personalize the treatment and care of patients, improve patient outcomes, and substantially reduce heath care costs.
Founded in October, 2006, the Coalition was organized in response to new initiatives by the FDA and Congress that we believed would profoundly impact our ability to deliver needed, next generation in vitro diagnostic services to health care professionals and their patients and threatened the evolution of personalized medicine.
The Coalition began with two specific goals to advance personalized medicine:
- 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; and
- To expand patient, public and policymaker understanding of the importance and promise of innovative molecular diagnostics and personalized medicine to the detection, treatment and cure of chronic, serious and life-threatening illnesses, conditions and diseases, including by working with the Congress.
What We Believe
We believe that innovation is the key to 21st century medicine and that access to advanced diagnostic products and services are key to the future of quality, affordable healthcare. We share a passion for ensuring that high quality, innovative diagnostic tests are available to patients and physicians in a transparent and timely fashion.