ACLA warns FDA move to regulate LDTs conflicts with White House proposal

Feb. 2, 2015

The American Clinical Laboratory Association (ACLA) recently 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),” says 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.

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 The FDA issued draft guidance documents to newly regulate LDTs in October 2014 over the vigorous opposition of the lab community.

Learn more on the ACLA website

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