AACC Welcomes HHS Decision to Clarify Federal Regulation of Laboratory Developed Tests

Statement attributable to:

David G. Grenache, PhD

President, American Association for Clinical Chemistry

“AACC welcomes a decision from the Department of Health and Human Services that the Food and Drug Administration does not have authority to regulate laboratory developed tests (LDTs) without formal notice-and-comment rulemaking. Led by highly educated, board-certified laboratory directors—many of whom are AACC members—laboratories that perform LDTs already meet stringent regulatory requirements under the Clinical Laboratory Improvement Amendments. These regulations assure only scientifically valid, high quality services are provided to patients.

“LDTs are critical in our nation’s healthcare enterprise. It was CLIA-regulated laboratories that developed, validated, and performed LDTs for COVID-19 before commercially marketed tests became available. Unlike commercial test kits sold by manufacturers to various healthcare entities, laboratory-developed tests are used only by the lab that created them. AACC looks forward to continuing to work with HHS, FDA, and this administration to ensure that patients receive accurate, timely testing unhindered by duplicative federal regulation.” 

Since the beginning of the COVID-19 outbreak, AACC has been working with the administration to ensure access to vital laboratory testing. AACC has provided laboratory professionals with the latest guidelines from CDC and FDA to help them to develop and validate accurate, reliable tests for COVID-19. AACC is also conducting an ongoing survey of laboratories performing COVID testing to help identify pressure points or challenges labs are facing. 

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.aacc.org.