Laboratory Developed Tests (LDTs) play a vital role in modern medicine, aiding in diagnosis and treatment decisions. The regulatory landscape surrounding LDTs has been a topic of debate for years. But thanks to a recent major Supreme Court ruling, as well as ongoing litigation, the future of FDA regulation of LDTs is very much up in the air.
Let’s explore the background, current situation, and the future of the FDA’s position on managing risk and oversight of LDTs.
What Exactly is an LDT?
A laboratory developed test, or LDT, is a diagnostic test designed, manufactured, and used within a single specific laboratory. These tests analyze samples like blood, tissue, or saliva to diagnose or monitor medical conditions. LDTs differ from commercially available tests in that they are not sold or distributed to other labs.
The Rationale for Change
The FDA, responsible for ensuring the safety and effectiveness of medical devices, has historically exercised enforcement discretion for most LDTs. This essentially meant they haven’t enforced the same regulations as for other diagnostics, and other agencies (e.g. CMS, CLIA) have been considered as potentially appropriate authorities for effective oversight.
The FDA argues that increased oversight is necessary to ensure the safety and effectiveness of all diagnostic tests, including LDTs. They point to concerns about the potential for inaccurate results with some LDTs, which could lead to misdiagnosis and improper treatment. Additionally, the lack of standardized regulations creates an uneven playing field for LDT developers compared to commercially available diagnostics.
The FDA Rule
In May 2024, the FDA finalized a new rule that would increase oversight of LDTs. This rule would have gone into effect in May 2025, with a roll-out period. In addition, there are certain exemptions written into the rule.
The rule aims to bring LDTs under the umbrella of FDA regulations for In Vitro Diagnostics (IVDs). This would mean LDT developers would need to comply with various requirements, potentially including:
- Premarket review: Submitting data demonstrating the test’s safety and effectiveness.
- Quality system requirements: Implementing procedures to ensure consistent test quality.
- Adverse event reporting: Reporting any serious problems encountered with the test.
The rule sparked debate within the medical community. Some stakeholders support the FDA’s efforts to ensure safety and fairness. Others worry about the potential impact on access to innovative LDTs, particularly those developed by smaller laboratories.
The Future of LDT Regulation
It is unclear at this time whether the final rule will ultimately take effect. There are currently three major pressure points that may delay or scuttle the rule.
First, in June 2024, the Supreme Court overturned a landmark 1984 decision in Chevron vs Natural Resources Defense Council, with a 6-3 ruling. As a result, lower courts will no longer simply defer to regulatory agencies when congressional laws are ambiguous, and the ability of agencies to interpret law and enforce rules will be seriously curtailed.
Second, there are legal actions currently in process, including litigation initiated by the American Clinical Laboratory Association (ACLA), and supported by multiple professional organizations The ACLA disputes the FDA’s authority to regulate LDTs, arguing that if one considers an LDT a professional service vs a manufactured device, oversight should fall under Centers for Medicare & Medicaid Services via the Clinical Laboratory Improvement Amendments (CLIA).
Finally, in July 2024, the House Appropriations Committee approved $3.5B to FDA but with a recommendation to suspend the final rule and partner with Congress to modernize regulation of LDTs. Many professional organizations are in agreement that the LDT regulations do need to be updated but believe that this can and should happen through Congress.
In addition, members of Congress have introduced Congressional Review Act resolutions to repeal the FDA’s final rule on LDTs. It remains to be seen if these efforts will be successful.
How HcFocus Can Assist
It’s important to stay informed about the evolving regulations to understand the potential impact on how LDTs are developed, used, and accessed. HcFocus provides an integrated approach to market access. Certainly, while it remains unclear when or even if the new rule will take effect, a team approach that encompasses and aligns both regulatory and reimbursement concerns is imperative. Timing is really everything when it comes to the new FDA rule. Understanding potential exemptions may be most relevant. While for other companies, although potentially burdensome, complying with the new FDA rule may give our clients another opportunity to highlight the patient benefits of their tests and smooth the path to reimbursement.
References
FDA: Final ruling
FDA: Laboratory Developed Tests
American College of Medical Genetics and Genomics (ACMG): Laboratory Developed Tests (LDTs) and Additional Resources
American Clinical Laboratory Association (ACLA): LDT Rule Override Takes Center Stage as ACLA, Congress Seek to Undo Rule
Scotus Blog: Supreme Court strikes down Chevron, curtailing power of federal agencies
ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices – American Clinical Laboratory Association
MedTech Dive: House committee tells FDA to suspend lab developed test rule CAP: Pathologists Hold Capitol Hill Briefing to Promote Diagnostics Reform and the VALID Act