WASHINGTON – For today’s Senate hearing on laboratory testing in the era of precision medicine, AACC reiterated its position that regulation of laboratory developed tests (LDTs) should remain under the Clinical Laboratory Improvement Amendments (CLIA), rather than expanding Food & Drug Administration’s (FDA’s) oversight of LDTs. In a letter to the Committee on Health, Education, Labor, and Pensions (HELP), AACC advocated for the Centers for Medicare and Medicaid Services (CMS) to revise parts of CLIA to address the concerns raised by FDA and other stakeholders, rather than introduce costly and burdensome dual regulations for laboratories generating these critical tests, regulations that have yet to be proven necessary or effective.
CMS under CLIA already has in place the necessary framework to perform the functions proposed by FDA. Adding another layer of oversight would introduce delays and disincentives to innovation. A crucial importance of LDTs is ensuring patient access to a robust pipeline of innovative tests. LDTs enable labs to quickly assist physicians in diagnosing rare or new conditions for which no commercial tests exist, such as HIV and SARS when they initially emerged.
“Modernizing CLIA to address the issues raised by proponents of FDA oversight of LDTs would achieve the goal of ensuring clinical validity without the prohibitive administrative burden of dual oversight by FDA and CMS,” said AACC CEO Janet B. Kreizman. “We urge Congress and policymakers to support laboratory testing innovation and patient access to these life-saving tests by keeping regulation of LDTs under CMS.”
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.