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AdvaMedDx — 2018

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 2018, AdvaMedDx advocacy was critical to supporting diagnostics developers and advancement of pro-innovation policy reforms. These efforts included:

  • Advancing development of pro-innovation diagnostics regulatory reform legislation on Capitol Hill to create a risk-based, predictable pathway to market for all diagnostic tests ­– whether developed by laboratories or in vitro diagnostics companies – and to pursue risk-based regulatory efficiencies for all diagnostic test makers. Key progress points included FDA release in August of “technical assistance” on a framework for reform with provisions for precertification, which would facilitate market access for new diagnostic technologies and support keeping pace of science for certain test modifications. Progress was facilitated through AdvaMedDx thought leadership and establishment of a broad stakeholder coalition for reform, led by AdvaMedDx and the American Clinical Laboratory Association (ACLA).
  • Development of a proposal being considered by the Centers for Medicare and Medicaid Innovation (CMMI) to incentivize use of diagnostic tests, along with clinical guidelines, to help reduce inappropriate prescribing of antibiotics and antimicrobial resistance (AMR).
  • Progress in collaboration with laboratory stakeholder partners in building bipartisan support for legislation to mitigate Medicare payment reductions mandated by the Protecting Access to Medicare Act. AdvaMedDx also worked with CMS to secure some relief through administrative changes. 

AdvaMedDx also continued its broader advocacy and public affairs activities in the U.S. and globally to promote the value of diagnostic tests. In 2018, AdvaMedDx focused on areas of critical importance to patient and public health, including AMR. Specific initiatives included:

  • Launching AdvaMedDx’s “Test To Treatment” value fact campaign with fact sheets, infographics and social media focused on AMR and point-of-care tests, highlighting clinical evidence of the value diagnostics bring to patient care.  
  • Joining with AdvaMedDx members in making commitments to action under the Centers for Disease Control and Prevention’s Global AMR Awareness Campaign.
  • Hosting with MedTech Europe a stakeholder engagement and awareness event on AMR at the 2018 World Health Assembly. Participants included member companies, WHO officials, and representatives from Doctors Without Borders, the Wellcome Trust, and FIND.
  • Facilitating the third annual moderated conversation among leaders of AdvaMedDx, ACLA, and the American Association for Clinical Chemistry at AACC’s Annual Meeting and Clinical Lab Expo.