By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program
For more than 4 years, a discussion has raged regarding whether the Food and Drug Administration (FDA) should move to actively regulate laboratory-developed tests (LDTs). LDTs are defined by the FDA as tests that are developed by a single laboratory for use only in that laboratory. Although the FDA acknowledges that laboratories that develop LDTs are acting as manufacturers and are subject to FDA jurisdiction, the agency has historically exercised enforcement discretion over LDTs. Essentially; this means that the FDA looks the other way when it comes to LDTs. This was reasonable when most LDTs were single-analyte, easily reproducible assays. In recent years, however, manufacturers have exploited the LDT classification to avoid FDA regulation of sophisticated tests that, in many cases, require complex and proprietary computer algorithms to generate results. Increasingly, these results are being used for clinical decision making and disease management. Last year, a New York Times editorial called attention to an LDT, OvaSure, which was designed to detect ovarian cancer at an early stage but was found to be inaccurate after its 2008 release and was pulled from the market 4 months later. At that time, the newspaper urged the FDA to issue draft guidelines for LDTs that have apparently been stalled within the agency for some time.
Earlier this month, groups on both sides of the LDT fence sent letters to Brian Deese, the Acting Director of the Office of Management and Budget (OMB), arguing for and against increased FDA regulation of LDTs. On the pro-regulation side, 5 United States Senators urged Mr. Deese to take prompt action to release for public comment the draft guidelines to regulate LDTs using a risk-based framework. The Senators cited a recent Centers for Disease Control and Prevention (CDC) review regarding an LDT used for the diagnosis of Lyme disease that raised serious concerns about the accuracy of the test and called for “open and transparent” oversight of LDTs.
On the anti-regulation side, 23 pathologists and non-physician laboratory directors urged the FDA to refrain from issuing “any draft, proposed, or final guidance document or rule that would purport to regulate LDTs”. The laboratory leaders claim that LDTs are not medical devices, that laboratories are sufficiently regulated under the Clinical Laboratory Improvement Amendments (CLIA), state laws and accreditation agencies, and that FDA regulation would limit access to testing and stifle innovation.
Where does Hayes stand on this issue? As stated in a previous blog post and in a white paper titled Regulation of Genetic Testing in the United States, Hayes believes that the current system of oversight of LDTs is not sufficient to ensure the safe and appropriate use of these tests in patient care. We believe that FDA guidance is desperately needed in this area and we urge the prompt release of the draft guidelines to move us toward a regulatory framework that will ensure the safety and effectiveness of LDTs.