WASHINGTON – On Thursday, December 6, House and Senate lawmakers released bipartisan draft legislation, known as the Verifying Accurate, Leading-edge In Vitro Clinical Test Development (VALID) Act, which outlines a framework for the Food and Drug Administration (FDA) to regulate laboratory developed tests. AACC will oppose this bill if, as in previous iterations, it promotes additional, duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests.
Laboratory developed tests are created in-house by labs to diagnose rare or new conditions for which no commercial tests exist, such as HIV and SARS when they initially emerged. Under the Clinical Laboratory Improvement Amendments (CLIA), an act that Congress passed in 1988 to establish uniform regulation of laboratory testing, these tests must currently meet stringent performance standards established by the Centers for Medicare and Medicaid Services (CMS) in partnership with the Centers for Disease Control and Prevention (CDC).
Test kits and devices developed by medical device manufacturers, on the other hand, are regulated by FDA because they are different and distinct from laboratory developed tests. Commercial diagnostic products are sold widely for use by multiple end users, unlike laboratory developed tests, which are developed and performed within a single clinical lab by uniquely qualified and knowledgeable practitioners in the field of laboratory medicine. These two separate regulatory processes—with FDA overseeing medical device manufacturers and CMS and CDC overseeing clinical laboratories—are well established and should be preserved. Forcing clinical laboratories to comply with FDA regulations in addition to those from CMS and CDC could cripple hospitals and smaller labs and force them to stop performing vital tests.
“AACC urges Congress, CMS, and CDC to update the already rigorous CLIA framework, as we firmly believe this is the most effective way to improve oversight of laboratory developed tests. This framework is the best way to foster innovative new tests and enable labs to meet the changing needs of patients,” said AACC President Dennis J. Dietzen, PhD. “We fear that treating clinical laboratories as medical device manufacturers and subjecting them to FDA oversight will force many laboratories to stop offering these tests thus limiting patient access to essential care.”
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.