On the heels of the recent U.S. Food and Drug Administration (FDA) announcement to hold off on finalizing its oversight policy for laboratory-developed tests (LDTs), clinical laboratories developing laboratory tests will be able to enjoy the benefits of their regulatory gray zone a bit longer. For how long is unknown since the FDA remains committed to finalizing an oversight policy for LDTs and said after November’s election that it will “continue to work with stakeholders, our new Administration, and Congress to get our approach right.”
It is unclear how new leadership at the FDA will apply and enforce the agency’s regulatory authorities against LDTs and whether the new administration will finalize, with little change, the FDA’s 2014 draft oversight framework or pursue a different approach entirely. However, for now, clinical laboratories may continue to market their tests using past approaches with little fear of enforcement action in the near-term, despite the FDA’s creation of an online portal this fall for submitting marketing complaints to its medical device center personnel.
Given the changing administration and transition phase that will follow as a new leadership team gets its bearings, clinical laboratories should continue positioning their LDTs in marketing materials in a manner consistent with LDTs against which the FDA historically has not taken enforcement action. Following are some best practices for marketing LDTs in a manner that has been outside of the FDA’s oversight focus:
1. Ensure the LDT is only promoted with claims that are truthful, not misleading, and can be substantiated with clinical data.
2. Ensure the LDT is represented as being for clinician rather than consumer or patient use.
3. Ensure the LDT is represented as having been designed, manufactured, and used within a single laboratory (phrases such as “developed onsite in our laboratory” are ideal for use in marketing).
4. Ensure the LDT is represented as having been verified and validated within that laboratory.
5. Ensure the LDT is represented as having been designed, manufactured, and used by a laboratory meeting the requirements for high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA).
6. Ensure the LDT is represented as using primarily analyte-specific reagents, general purpose reagents, general purpose laboratory equipment, and other laboratory instrumentation and controls.
7. Ensure LDT performance claims are supported by appropriate and meaningful data and that any discussion of those data discloses material facts, including limitations, of those data.
8. Ensure that LDTs developed using an analyte-specific reagent disclose on test reports for clinicians that the laboratory developed the test and it has not been cleared or approved by the FDA; sample test reports are often used in marketing materials.
9. Ensure the LDT is not represented as having been reviewed, cleared, or approved by FDA unless it has been submitted for review or received clearance or approval.
10. Ensure the LDT is not represented in a manner that makes direct or indirect comparative claims to legally marketed tests that have been cleared or approved by the FDA; doing so is likely to draw complaints from test makers who have obtained FDA clearance or approval and can draw the FDA scrutiny to LDTs marketed with such claims.
11. Ensure the LDT is not represented as diagnosing a disease or condition or prescribing a specific treatment course if the test only produces information about a patient that may help inform clinical decision-making (i.e., do not represent tests for unilateral use in diagnosis or treatment decisions if they are not intended that way).
12. Ensure LDT marketing materials do not include testimonials that make broad performance claims or statements, including quality of life claims, which the clinical laboratory itself cannot clinically substantiate.
The FDA has issued very few, if any, warning letters for laboratory tests in recent years. Laboratory test oversight has not traditionally been a priority for the FDA’s limited enforcement resources in the medical device arena, and that is unlikely to change. With a medical device user fee reauthorization in the year ahead, there may be congressional opportunities to shape the future of LDT agency oversight. In addition, industry groups are continuing to meet with congressional committees regarding policy proposals.
Clinical laboratories should keep abreast of the evolving regulatory landscape for LDTs as the threat of a sea change in regulatory oversight lingers. Moreover, clinical laboratories would be wise to begin assembling the data that would be necessary to submit to the FDA should its oversight policy down the road mandate premarket clearance or approval to continue marketing certain LDTs. However, until that time, LDT developers should continue to enjoy the FDA regulatory freedom that past policy has set in place.
