FDA Barred from Regulating Laboratory-Developed Tests After Industry Lawsuit

In a court judgment, the American Clinical Laboratory Association (ACLA), Association for Molecular Pathology (AMP), and their members won a case against the FDA, which has prohibited the FDA from regulating laboratory-developed tests (LDTs) under section 564 of their regulations.¹

United States District Judge Sean D. Jordan entered the final judgment to vacate the FDA’s rule on March 31, 2025.

FDA draft guidance from mid-2024 mentioned the agency’s plan to regulate LDTs using the guidelines it uses to regulate in vitro diagnostics and medical devices.² In accordance with the draft guidance process, this became a “Final Rule” within the FDA after a period of review. Professional pathology organizations like ACLA immediately responded that the FDA was operating outside its authority.³

“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach. The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products. These professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve,” stated Susan Van Meter, president of ACLA.³

In court, the FDA’s attempt was considered a direct violation of the Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments set by The United States Congress. Following the decision, the other plaintiff, AMP, responded in a press release.⁴

“AMP is extremely pleased with the court’s clear and decisive ruling in our favor, and we hope this will finally end the FDA’s attempts to exert an unwarranted overreach of authority of LDTs,” said Jane S. Gibson, PhD, president of AMP and chair of the Department of Clinical Sciences and director of molecular diagnostics at the University of Central Florida College of Medicine.

President Donald Karcher, MD, FCAP of the College of American Pathologists (CAP), told Blood Cancers Today, “the FDA’s LDT rulemaking was burdensome, and the court rightly struck it down.” Like many organizations representing the cancer pathology community, CAP noted that the Final Rule could have greatly interfered with cancer pathology.

Pathology reports provide hematologists/oncologists with data on how treatment is selected. CBC results are still key for detecting leukemia, lymphoma, and multiple myeloma, as are blood protein tests.⁵ In modern years, select blood cancers can be detected using circulating tumor cell tests, and even multicancer early-detection blood tests have shown utility in diagnosing blood cancer.⁶

“LDTs are crucial for us to give our patients an accurate diagnosis so we can both be confident we are embarking on the best treatment for their cancer, Uma Borate, MBBS, Clinical Section Head, Acute Leukemia and Clinical Research Director, Acute Leukemia at the Ohio State University Comprehensive Cancer Center told Blood Cancers Today.

Overall, LDTs have offered additional information for a more targeted approach to cancer treatment.

“The regulation failed to target FDA oversight and threatened patient access to countless numbers of safe LDTs by saddling laboratories with unnecessary requirements. The CAP and its members are relieved that the court agreed with our arguments,” Karcher said.

In a press release from ACLA, Van Meter also foresaw the impact, stating the FDA-regulated LDTS could “disrupt the paradigm, creating negative consequences for the entire health care system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide.”³

However, not all cancer pathology happens in the diagnostic stages. Every day, hematologists/oncologists depend on laboratory data to ensure patient-centered and evidence-based treatment.

“All treatment decisions are based on the pathology, and now, in particular, because of the targeted therapies we have, the pathology is more important than ever,” Steven T. Rosen, MD, executive vice president and director emeritus, Beckman Research Institute, City of Hope, told Blood Cancers Today. “Any impediment to getting the necessary tests available for our patients is detrimental,” he added.

Future regulations may continue to impact how laboratories operate, ultimately affecting patient care. Borate stated, “We would hope that the tests that tell us which disease that our patients have especially diseases like cancer, are held to the highest standards to make sure we are prescribing the most effective treatments for these patients.”

References

1. United States District Court Eastern District of Texas Sherman Division. Case 4:24-cv-00479-SDJ; Document 94: Page ID 2731. Filed March 31, 2025. Accessed April 8, 2025.
2. United States Department of Health and Human Services, United States Food and Drug Administration. Docket No. FDA-2024-D-008. Filed April 29, 2024. Accessed April 8, 2025.
3. ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices. News release. American Clinical Laboratory Association website. Published May 29, 2024. Accessed April 8, 2025. https://www.acla.com/acla-challenges-fdas-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/
4. Association for Molecular Pathology Celebrates U.S. District Court’s Decision to Vacate FDA Rule on Laboratory-Developed Test Procedure Regulation. News release. The Association of Molecular Pathology. Published March 31, 2025. Accessed April 8, 2025. https://www.amp.org/AMP/assets/File/pressreleases/2025/AMP-FDA-Positive-Ruling-FINAL_033125.pdf?pass=37
5. Cleveland Clinic Health Library. Blood Tests for Cancer. Cleveland Clinic. https://my.clevelandclinic.org/health/diagnostics/22338-blood-tests-for-cancer Last updated May 6, 2024. Accessed April 8, 2025.
6. Rubinstein W, Patriotis C, Dickherber A, et al. Cancer screening with multicancer detection tests: A translational science review. CA Cancer J Clin. 2024;74(4):368-382. doi:10.3322/caac.21833.