Association for Diagnostics & Laboratory Medicine (formerly AACC) Response to CMS Statement on FDA LDTs Proposed Rule

Statement attributable to: Octavia Peck Palmer, PhD President, Association for Diagnostics & Laboratory Medicine (formerly AACC)

“We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) were surprised to see a statement from Drs. Jeff Shuren and Dora Hughes from the Centers for Medicare & Medicaid Services (CMS) in support of the U.S. Food & Drug Administration’s (FDA’s) proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under CMS.

“As we have noted in the past, laboratory developed tests are currently subject to rigorous oversight under CLIA. Creating an expensive and potentially contradictory duel regulatory environment for clinical laboratories would eliminate most labs’ ability to perform laboratory developed tests and drastically limit patients’ access to critical laboratory test results.

“We know that the CMS and FDA share the goal of ADLM members — the expert lab directors overseeing the high-complexity labs where laboratory developed tests are created — to ensure patient safety and better health for all. To meet this goal, we must identify what problems we are trying to fix and correct them without hindering scientific advancement or limiting patient access to these innovative, often life-saving tests.”

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

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.