WASHINGTON – Today AACC released a position statement in response to the Food and Drug Administration’s (FDA’s) proposal for oversight of laboratory developed tests, asserting that most laboratory developed tests are sufficiently regulated by the Centers for Medicare and Medicaid Services (CMS), and that too much additional FDA oversight could prevent labs from helping underserved patient populations.
Defined as medical tests that are created and used within a single clinical lab, laboratory developed tests enable labs to diagnose rare or new conditions for which no commercial tests exist, such as HIV and SARS when they initially emerged. In recent years, however, the number and complexity of laboratory developed tests has increased dramatically. This increase led the FDA to release draft guidance on October 3 that proposes a risk-based oversight framework for laboratory developed tests. Under this framework, FDA would require high- and moderate-risk laboratory developed tests to go through the agency’s clearance or approval process. Low-risk laboratory developed tests would be subject to registration and listing with the agency, as well as adverse-event reporting.
AACC agrees with FDA that laboratory developed tests should undergo additional scientific scrutiny and oversight. However, the association is concerned that bringing all laboratory developed tests under FDA’s control could impede patient care—as well as advances in healthcare—by eliminating or significantly limiting the availability and development of these tests.
In this position statement, AACC notes its support for the FDA’s plan to categorize these tests as high, moderate, and low risk, but recommends limiting FDA regulation to joint oversight of the high-risk category with CMS. As the vast majority of laboratory developed tests are moderate and low risk, AACC believes that these tests should remain under the jurisdiction of CMS and its accreditation bodies. Currently, CMS subjects laboratory developed tests to the most stringent personnel, quality control, and proficiency testing standards under the Clinical Laboratory Improvement Amendments of 1988, and requires a laboratory director with an MD or PhD and specific board-certification to oversee the creation and use of all laboratory developed tests within a lab.
“Every day, in thousands of labs across the country, laboratory developed tests help healthcare providers diagnose and treat patients with cancer, infectious diseases, genetic disorders, and many other conditions,” said AACC CEO Janet B. Kreizman. “AACC urges the FDA to balance the need for additional oversight of these tests with safeguarding patient access to this vital healthcare service, and we recommend that the agency work with other healthcare stakeholders to determine which laboratory developed tests should be subject to FDA requirements.”
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 breaking 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.