Statement by the American Clinical Laboratory Association on the FDA Report on LDTs

(WASHINGTON, DC) – The American Clinical Laboratory Association (ACLA) provided an initial response today to a report issued by the Food and Drug Administration (FDA) on oversight of laboratory developed tests (LDTs), saying the regulatory agency continues to disparage the highly innovative field of clinical laboratory medicine by compiling outdated anecdotes that in many cases are recycled and speculative. These so-called case studies are not representative of the thousands of LDTs utilized on a daily basis by providers to positively impact patient care.

ACLA noted upon initial review that much of the data in the report is not based on peer-reviewed literature, refer to outdated data or tests no longer being offered, and that the current peer-review process among highly trained professionals was effective in many of these cases. The report also fails to make any comparison of degree or frequency between the alleged errors amongst LDTs relative to problems seen in the post-market of FDA approved or cleared products.

“Clinical laboratories and LDTs are currently highly regulated and when a small number of case studies are used to characterize an entire dedicated and compassionate industry, it detracts from the true task at hand – and that is to effectively strengthen the current regulatory framework for LDTs in a way that continues to advance diagnostic innovation,” said Alan Mertz, President of ACLA. “The FDA’s own proposed guidance to regulate LDTs would be highly disruptive to laboratory services and compromise patient care.”

ACLA is continuing to review the FDA report and reiterated its commitment to working with Congress on reforming clinical laboratory oversight through the legislative process to ensure patient access to accurate, reliable laboratory services that advance personalized medicine.

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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. 

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