Laboratory Developed Tests

ACLA Lauds President’s Precision Medicine Initiative, Warns FDA Move to Regulate Laboratory Developed Tests (LDTs) Conflicts with White House Proposal

WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) today commended the White House’s Precision Medicine Initiative intended to accelerate advances in disease treatment and cures, but warned the FDA proposal announced last year to regulate laboratory developed testing services (LDTs) will work against the very medical innovation supported by the initiative.

“The clinical laboratory community applauds the President’s leadership in the area of personalized medicine, particularly the new funding proposed for the National Institutes of Health (NIH) and National Cancer Institute (NCI),” said Alan Mertz, President of ACLA.

The Precision Medicine Initiative proposes $200 million in new funding for the NIH, including $70 million to the NCI. The program directs the DNA sequencing of up to a million Americans with the intention of yielding information that could rapidly advance groundbreaking discoveries and ultimately, clinical outcomes for patients.

“However, the FDA’s push to regulate laboratory developed testing services through the ‘Draft Guidance’ documents issued last year would dramatically slow patient access to vital diagnostic tools and runs counter to the President’s new initiative to promote precision medicine,” said Mertz. “Most of the new molecular and genetic diagnostic tests that are at the very heart of precision medicine are LDTs, and FDA’s proposal would severely impede the development of new LDTs and the advancement of precision medicine.”

Laboratory-developed testing services are tests that are developed, validated, and performed by highly-trained and certified professionals within a single clinical laboratory entity. LDTs have been comprehensively regulated by CMS, which administers the detailed requirements Congress enacted under the Clinical Laboratory Improvements Act (CLIA), as well as by state regulators. Physicians routinely depend on LDTs to assist in making crucial medical decisions about the best course of treatment for their patients. The FDA issued draft guidance documents to newly regulate LDTs in October 2014 over the vigorous opposition of the lab community.

“Putting patients first has to be the priority for any healthcare initiative and the Precision Medicine Initiative can serve as a landmark program that brings the future of scientific discovery rapidly into the present,” said Mertz.

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