ADLM commends federal court's decision to vacate the FDA's final rule regulating laboratory developed tests

WASHINGTON, April 1, 2025 /PRNewswire/ -- 

Statement attributable to:
Anthony Killeen, MD, PhD
President, Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC)

"ADLM applauds the U.S. District Court for the Eastern District of Texas for issuing a decision to vacate the Food and Drug Administration's (FDA's) final rule to regulate laboratory developed tests as medical devices. The court found that the FDA rule would have negatively impacted testing on which patients and clinicians depend, and that the rule also went against Congress' intent, which is for laboratory services to be regulated under the current framework administered by the Centers for Medicare & Medicaid Services (CMS).

"This is a major victory for patients, as laboratory developed tests play an indispensable role in enabling patients to get timely diagnoses and care for conditions ranging from cancer to emerging infectious diseases. The FDA rule — which would have started to go into effect on May 6 — would have subjected these tests to duplicative, burdensome, and costly FDA-CMS regulation. This would have forced many labs to stop offering these essential tests.

"This court ruling was made in response to lawsuits filed by both the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) against the FDA. ADLM filed an amicus brief in support of ACLA's lawsuit along with the American Association of Bioanalysts, American Society for Clinical Pathology, American Society for Microbiology, and the Infectious Disease Society of America. Many others in the laboratory medicine community also contributed to ACLA and AMP's cases. We are immensely grateful that the court listened to the voices of the laboratory medicine professionals who create, validate, and perform laboratory developed tests, and that the court took our expertise and experience into account when making its decision.

"Moving forward, ADLM will continue to engage collaboratively with regulatory agencies and Congress to ensure that the regulatory framework for laboratory developed tests always fosters the best possible outcome for patients. We encourage the FDA and those who supported its final rule to join with us to ensure that these tests are of the highest quality without limiting patient access or innovation."

To speak to Dr. Killeen about this issue, please contact Christine DeLong, ADLM Associate Director of Communications & PR, at [email protected] or 202-835-8722.

About laboratory developed tests
A laboratory developed test is a new or significantly modified test that is developed, validated, and used within a single clinical laboratory in response to a specific patient care need. Most laboratory developed tests are created because there is not already a Food and Drug Administration-approved test available, and they are often used to diagnose rare conditions, such as inherited genetic disorders. These tests are typically not advertised or sold as kits to other testing facilities.

The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity labs under the Clinical Laboratory Improvement Amendments, which are administered by the Centers for Medicare & Medicaid Services (CMS). These high-complexity labs are subject to rigorous oversight under CMS, and they are routinely inspected to ensure that they provide highly accurate testing.

About the Association for Diagnostics & Laboratory Medicine (ADLM)
Dedicated to achieving better health through laboratory medicine, ADLM (formerly 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, ADLM 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.

SOURCE Association for Diagnostics & Laboratory Medicine (ADLM)