WASHINGTON, D.C. – In a letter to the Senate Health, Education, Labor and Pensions Committee (HELP), the American Clinical Laboratory Association (ACLA) today applauded the Committee for holding a hearing on the regulation of laboratory developed tests (LDTs) and outlined ten key principles to guide any reforms to oversight of these tests.
“We are heartened that Chairman Alexander (R-TN) and Ranking Member Murray (D-WA) are hosting a hearing on the value and role of LDTs, particularly in the context of precision medicine,” said Alan Mertz, President of ACLA. “LDTs are a major catalyst for the Precision Medicine revolution, and their critical role is often overlooked. For this revolution to continue, it’s critical that there be a clear and reliable regulatory system that doesn’t hamper LDT innovation, and that patients and doctors have continued access to these vital tests.”
In a letter to the Committee today, ACLA outlined key principles for any new statutory framework for modernizing the regulation of LDTs. Included among the principles are that LDTs are not medical devices and cannot be regulated by the Food and Drug Administration (FDA) as such, and that any new framework must grandfather existing LDTs. To view the full letter, click here.
“Putting the patient first is the priority for clinical lab scientists and diagnostic researchers across the country,” said Mertz. “The clinical lab community appreciates the opportunity to continue to work with members of Congress and stakeholders with the objective of strengthening the current regulatory framework for these tests. Legislative reform is the most transparent and practical solution to ensure diagnostic innovation remains a leading factor in developing effective treatments and cures for disease.”
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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.