WASHINGTON – Today, AACC sent a letter to the House Energy & Commerce leadership in response to draft legislation proposing additional federal oversight of laboratory developed tests. In its statement, AACC recommended modifying the current regulatory structure for these tests instead of introducing costly, burdensome regulation that could hinder patient care.

There are many rare or new medical conditions for which no commercial test exists, and clinical laboratories have traditionally filled this void by creating medical tests in-house. These tests are known as laboratory developed tests. The Centers for Medicare and Medicaid Services (CMS) currently ensures the quality and accuracy of these tests. As the number and complexity of laboratory developed tests has increased in recent years, however, some healthcare groups have become concerned that the established regulatory framework for the tests is not sufficiently rigorous. This has led some congressional representatives to propose the creation of a new center within the Food and Drug Administration (FDA) tasked with oversight of all laboratory tests, including laboratory developed tests.

AACC agrees with certain aspects of the proposal, such as the need for labs to demonstrate the accuracy of laboratory developed tests, and the exemption from greater regulatory scrutiny granted to critical tests such as those for newborn screening, unmet needs, or public health emergencies. However, the association is concerned that a dual regulatory structure will impede patient access to testing, since many hospitals and rural testing facilities do not have the resources to comply with FDA’s requirements and would be forced to stop performing laboratory developed tests.

As an alternative to the draft legislation’s proposal, AACC recommends that Congress use the existing regulatory framework under CMS to enhance the oversight of laboratory developed tests. For example, the draft legislation would require labs to provide the FDA with a listing of the laboratory developed tests performed at that lab. The more logical repository of this information would be CMS, however, because the agency already requires labs to submit a laboratory activity list that includes all laboratory developed tests. AACC also recommends that CMS assume responsibility for assessing the clinical validity of laboratory developed tests, which would be a relatively minor adjustment considering many CMS-accredited laboratories are already required by private accrediting bodies to demonstrate clinical validity. 

“AACC believes the current regulatory structure can be adapted to tackle concerns regarding laboratory developed tests without introducing dual oversight for which there is no evidence of need, nor proof of improvement over the current system,” said AACC CEO Janet B. Kreizman. “Although AACC supports some of the concepts outlined in the proposal, we fear that if enacted, the proposed bill would foster an anti-competitive environment that favors the few laboratories with sufficient resources to meet FDA requirements, thereby limiting patient access to vital tests and causing testing costs to rise.”


About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.