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test services through the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) and the Analyte Specific Reagent (ASR) Draft guidance documents.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.