Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot
Bill Cassidy - Ranking Member of the Senate HELP Committee | Official U.S. Senate headshot
WASHINGTON – U.S. Senator Bill Cassidy, M.D., the ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, has called for feedback from stakeholders on ways to enhance the regulation of clinical tests in the United States.
Cassidy emphasized the significance of clinical tests in healthcare decisions, stating, "Clinical diagnostics play a critical role in our health care system, influencing nearly 70% of all health care decisions." He highlighted the need for regulatory oversight to ensure the continuous progress, safety, and accuracy of diagnostic technologies, especially in the context of precision medicine and personalized therapies.
Acknowledging the evolving landscape of medical advancements, Cassidy pointed out the necessity for improvements to the regulatory frameworks governing laboratory services and diagnostic products. He noted that stakeholders and policymakers widely agree on the need for reforms in the regulation of clinical tests.
In his call for feedback, Cassidy outlined key areas for consideration, including the FDA regulatory framework for diagnostics and the CLIA regulatory framework for Laboratory Developed Tests (LDTs). He posed specific questions to stakeholders, seeking insights on various aspects of regulatory oversight and potential areas for improvement.
Interested parties have been invited to submit their responses to diagnostics@help.senate.gov by April 3, 2024, to contribute to the ongoing discussions on enhancing the regulation of clinical tests in the United States.
For more information and updates from HELP Republicans, please visit their website or follow them on Twitter at @GOPHELP.
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