Achieving Our Goals — Today and Tomorrow
Founded in 2006, the Coalition began with two specific goals:
- Work with Congress, academics, investors, clinicians, and patient groups to better support investment in commercialization of high value advanced diagnostics and to support the development of an improved legislative framework to enhance the promise of innovative molecular diagnostics and personalized medicine in the detection, diagnosis, treatment, and cure of diseases.
- Engage the FDA to retract or substantially modify its proposal to reduce enforcement discretion and regulate, for the first time, laboratory developed test services through the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) and the Analyte Specific Reagent (ASR) Draft guidance documents. Our key objectives were formulated to ensure an appropriate regulatory environment that recognizes the difference between laboratory operations and medical devices, was not overly burdensome, and served to support and sustain innovation in the development of molecular diagnostics. The goal was to advance personalized medicine by proposing and advocating a more rational, risk balanced regulatory approach based on the test result impact on patients as opposed to the test’s underlying technology platform or company business model.
The Coalition for 21st Century Medicine is in its tenth year of work dedicated to innovation in the field of advanced diagnostic laboratory tests (ADLTs). Over the past decade the Coalition has been a leading voice on policy issues for advanced diagnostic technologies.
Our agenda for the coming year is equally ambitious and promises to be equally successful. In 2016, the Coalition will:
Engage with FDA Regarding Laboratory Diagnostic Tests (LDTs)
We will continue to communicate with the FDA regarding appropriate pre-market oversight of LDTs and will begin to further engage on regulation of other LDTs.
Work to Improve Coding, Coverage, and Reimbursement
We will work toward modernizing the framework for coding, coverage, and reimbursement of advanced diagnostics, to better reflect the value of these innovative technologies.
Promote Personalized Medicine Legislation
We will work with Congressional sponsors of the personalized medicine legislation to introduce the bills and secure their consideration by key committees.
Advocate for Education on Next Generation Sequencing
We will work to highlight the need to improve education on next generation sequencing.