Statement attributable to:
Stephen R. Master, MD, PhD
President, American Association for Clinical Chemistry

“We share the FDA’s goal of alerting the public to the potential misuse of non-invasive prenatal screening (NIPS) tests. As the FDA notes, screening tests are designed to identify someone who potentially has a condition. If the person screens positive, a diagnostic test is performed to make a definitive determination. It is imperative that both physicians and patients understand this distinction, and that any medical claims for testing are supported by rigorous science.

“This is why we’ve been advocating for the modernization of how laboratory-developed tests (LDTs) are regulated by the Centers for Medicare and Medicaid Services (CMS). LDTs are used to diagnose a wide variety of medical conditions, such as predisposition to breast cancer and other genetic conditions, as well as lead poisoning in children. AACC supports CLIAC, the federal advisory committee for CLIA (the mechanism under which LDTs are regulated by CMS), discussing whether additional LDT oversight is necessary and, if so, what that level of regulation should be. We urge the FDA, which sits on that panel, to join with us to make any necessary changes. No legislation is necessary to achieve this goal. 

“Despite this fact, rather than join with us and many other stakeholders in holding these discussions, the FDA has been publicly supporting the provisions proposed in new federal legislation. The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 would create a dual, expensive, and potentially contradictory regulatory environment for labs that eliminates the ability of many labs to perform LDTs, thus limiting patients’ access to critical laboratory test results. In conflating educational needs about NIPS with the overall regulation of LDTs, the agency highlights a political agenda rather than addressing the issue at hand.

“Specifically, we believe that by curtailing the ability of regulated, high-complexity laboratories to rapidly develop LDTs in response to clinical need, the FDA’s oversight would have unintended consequences that will result in delayed or less accurate test results for patients. It will also limit the laboratory community’s ability to rapidly respond to emerging threats to health, such as new drugs of abuse. We do not believe that this approach best serves the public health.

“AACC strongly supports efforts to improve physician and consumer education of NIPS, but we equally strongly oppose efforts to use this need for education to advance policies that would impair our ability—as laboratory medicine physicians and scientists—to respond to diagnostic needs. FDA oversight of LDTs would do just that.”

To speak to Dr. Master about this issue, please contact Molly Polen, AACC Senior Director of Communications & PR, at [email protected] or 202-420-7612.

About AACC

Dedicated to achieving better health through laboratory medicine, AACC brings together more than 70,000 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.