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2017 AdvaMedDx

Diagnostics For Better Health

Operating as a division of AdvaMed, AdvaMedDx advocates on behalf of the world’s leading diagnostics manufacturers and promotes the value of diagnostic tests for better health and better care.

In 2017, AdvaMedDx advocacy was critical to supporting diagnostics developers and advancement of pro-innovation policy reforms. These efforts included:

  • Continuing work on reforming diagnostics oversight and working closely with FDA, key congressional committees and other stakeholders to advance and promote a risk-based approach to improve the regulatory process for all diagnostics.
  • Ensuring appropriate access to bio-specimens for test development by successfully defeating a proposed regulatory update that would have required research involving non-identified bio-specimens to be subject to the Common Rule, and that consent be obtained in order to conduct such research.
  • Supporting FDA implementation of 21st Century Cures Act provisions, including long-standing AdvaMedDx recommendations for expanded rare disease testing, CLIA-waiver performance and process improvements, as well as exemptions for Class I and II diagnostics.
  • Working closely with the Centers for Medicare and Medicaid Services (CMS) and other stakeholders to ensure effective implementation of clinical diagnostic laboratory test payment reforms under the Protecting Access to Medicare Act.

AdvaMedDx continued its broader advocacy and public affairs activities in the U.S. by partnering with stakeholder organizations and producing educational materials on the value of diagnostic tests. In 2017, AdvaMedDx focused on areas of critical importance to patient and public health, including infectious diseases and antimicrobial resistance. Specific initiatives included:

  • Organizing two Capitol Hill briefings focused on diagnostic tests for emerging infectious disease threats and precision medicine.
  • Facilitating the second annual moderated conversation among the leaders of AdvaMedDx, the American Clinical Laboratory Association, and the American Association for Clinical Chemistry at AACC’s Annual Meeting and Clinical Lab Expo.
  • Developing and promoting the Framework for Comprehensive Assessment of the Value of Diagnostic Tests in collaboration with Deloitte Consulting, which provides a comprehensive approach for assessing the value of diagnostic tests.
  • Partnering with a number of stakeholders, including physician groups, patient groups, research institutions and pharmaceutical companies, to host an Antibiotic Resistance Awareness Fair on Capitol Hill during U.S. Antibiotics Awareness Week.