Laboratory Developed Tests

Statement from the American Clinical Laboratory Association in Response to the Wall Street Journal story entitled Is Lab Testing the ‘Wild West’ of Medicine?

The Wall Street Journal story published today entitled Is Lab Testing the ‘Wild West of Medicine’ focuses on the Food and Drug Administration’s (FDA) move to regulate laboratory developed tests (LDTs) and inaccurately implies that regulation of the clinical laboratory industry is scant and ineffective. The story fails to even reference the law under which labs are regulated or describe the existing framework for oversight. The Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvements Act (CLIA) has had oversight of the industry for decades. CLIA establishes quality standards, inspections, user-fees, and penalties for non-compliance. In addition, all such laboratories are subject to inspection and licensure by state health authorities. It would have been helpful to include this information to the reader and provide a greater understanding of the existence and extent of current regulation.

In addition, when reporting on a recent brief by the FDA that focuses on twenty LDTs out of as many as 10,000 currently being used, as proof of a lack of oversight negatively impacting patient care, it would have benefitted the reader to know that the agency used media reports rather than recently published scientific evidence to mischaracterize the efficacy of certain tests.

ACLA has maintained that the current proposal by the Food and Drug Administration (FDA) would duplicate regulations and costs at the expense of patients.  LDTs are the product of collaborative practice among laboratory physicians, geneticists, and PhD scientists and are not physical articles off an assembly line.  The fact that LDTs may share some of the same purposes and functions with FDA-regulated in vitro diagnostic (IVD) test kits does not make them medical devices, as the FDA wrongly asserts and is reported in the WSJ article.

ACLA has long supported modernizing and strengthening the CLIA statute as the world of diagnostic discovery leads us deeper into genomic science and nearer to clues for cures. Our goal is to promote and support diagnostic innovations that provide physicians with the information necessary to advance patient care and save more lives.

 

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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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