A federal judge has ruled against the U.S. Food and Drug Administration (FDA) regarding its authority to regulate laboratory-developed tests (LDTs), delivering a significant victory for diagnostic laboratories and potentially reshaping the regulatory landscape for in vitro diagnostics in the United States.
On March 31, Judge Sean Jordan of the U.S. District Court for the Eastern District of Texas vacated "in its entirety" the FDA's final rule on LDTs, which was issued in May 2024. The judge determined that the agency had exceeded its statutory authority in attempting to regulate these tests under the Federal Food, Drug, and Cosmetic Act.
Court Ruling Details
The lawsuit was brought by the American Clinical Laboratory Association (ACLA), member company HealthTrackRX, and the Association of Molecular Pathology (AMP), who challenged the FDA's authority to regulate LDTs, which are diagnostic tests designed, manufactured, and performed within individual laboratories.
In his ruling, Judge Jordan emphasized that Congress had "considered but declined to enact several bills over the past two decades that would have reshaped the regulatory framework over laboratory-developed test services." He further stated that "agencies cannot circumvent, and courts must enforce, the statutory framework Congress enacted as it exists."
The judge also highlighted the substantial economic burden the FDA's regulation would have imposed, noting that the rule would have affected approximately 79,114 existing tests offered by 1,181 laboratories, with compliance costs estimated to exceed $1 billion annually. Over two decades, the FDA had projected total costs associated with the rule would range from $12.57 billion to $78.99 billion.
Impact on the Diagnostic Industry
The court's decision has significant implications for companies developing diagnostic tests. Under the now-vacated rule, laboratories would have been required to comply with Medical Device Reporting requirements, correction and removal reporting requirements, and quality system standards regarding complaint files.
Susan Van Meter, President of ACLA, called the ruling "a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country."
For companies like Immunovia, which develops diagnostic tests for diseases such as pancreatic cancer, the ruling represents a regulatory tailwind. While many diagnostic companies may still pursue FDA approval for strategic reasons such as improved reimbursement pathways, such approval will now be optional rather than mandatory.
Background on LDTs
Laboratory-developed tests are diagnostic in vitro tests for clinical use that detect relevant biomarkers in patient samples such as saliva, blood, or tissues. These tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens to diagnose illnesses and guide treatment decisions.
LDTs play a crucial role in personalized medicine, offering tests that can assess the risks of developing conditions like Alzheimer's disease, detect the presence of various cancers, or guide treatment decisions for diseases such as breast cancer.
Current Regulatory Framework
Prior to the FDA's attempted regulation, LDTs were primarily regulated under the Clinical Laboratory Improvement Amendments (CLIA), which establishes quality standards for laboratory testing. The court affirmed that CLIA had established the appropriate and adequate system for regulating the quality, safety, and efficacy of LDTs.
Critics of the FDA's rule had argued that the agency was attempting to justify its expanded oversight based on a limited number of problematic test reports. According to court documents, the FDA cited issues with only nine different tests between 2009 and 2023 as part of its justification for the sweeping new regulations.
Looking Forward
While the ruling represents a significant setback for the FDA's regulatory ambitions, it is unlikely to be the final chapter in LDT regulation. The matter has been remanded to the Secretary of Health and Human Services, currently Robert F. Kennedy Jr., for further consideration.
Industry analysts suggest that while the immediate regulatory burden has been lifted, diagnostic companies should continue to maintain high standards for test validation and performance to ensure patient safety and clinical utility.
For investors and industry stakeholders, the ruling creates a more favorable environment for innovation in the diagnostic sector, potentially accelerating the development and commercialization of novel tests while reducing regulatory costs and timelines.
