Press Releases

AdvaMedDx Applauds Hill’s Release of FDA’s Technical Assistance to Advance Legislation to Modernize Regulation of Clinical Diagnostics

Washington, D.C. – AdvaMedDx applauds Capitol Hill’s release of technical assistance (TA) developed by the Food and Drug Administration (FDA) to draft legislation authored by Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) as a significant, positive step toward enacting legislation modernizing regulation of all diagnostics, including Laboratory Developed Tests (LDTs).

AdvaMedDx has long supported FDA oversight of all diagnostics, including LDTs, under a risk-based approach that promotes the public health and innovation.

“Innovative medical diagnostic tests and technologies are the foundation for evidence-based medicine, allowing for early intervention that improves patients’ health outcomes, often lowering costs for the broader health system. The FDA’s technical assistance in support of a modernized and predictable, regulatory framework for all diagnostic tests, will allow further progress on Capitol Hill toward enacting legislation to speed the pace and reach of cutting edge diagnostics, allowing patients to benefit more broadly, rapidly, and confidently, from the latest diagnostic technologies,” said Susan Van Meter, Executive Director of AdvaMedDx.

Over the past several years FDA has made strides to improve the regulatory process for diagnostics through flexible, efficient approaches to help pave the way for new advances, including personalized medicine. This TA is a step forward in efforts to advance a risk based approach to regulation of clinical diagnostics that promotes the public health and innovation.

Today AdvaMedDx joined several patient groups, laboratory and provider associations in sending a letter to the Chairmen and Ranking members of the Senate Committee on Health, Education, Labor & Pensions (HELP) and House Energy and Commerce Committee, appreciating the release of the FDA’s TA as an important and necessary next step in the pursuit of comprehensive legislative reform. We urge Congress to move swiftly to enact comprehensive diagnostics regulatory reform legislation. To view the full letter, click here.

 “As we review the TA released by the FDA, we look forward to continuing to work with Congress, the FDA, and the broad range of stakeholders with whom we share the goal of making diagnostics reform a reality,” said Van Meter.

About AdvaMedDx

PRESS CONTACT: Elyse Petroni, [email protected], 202-434-7271

AdvaMedDx member companies produce innovative, high quality in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and can reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies in the United States and abroad.