FDA Declines to Appeal Court Ruling on LDT Oversight

The 60-day window for the U.S. Food and Drug Administration (FDA) to appeal a recent U.S. District Court ruling on the regulation of laboratory-developed tests (LDTs) expired over the weekend—marking a pivotal moment for the clinical laboratory community. 

In response, the Association for Molecular Pathology (AMP) issued a statement from its President, Jane S. Gibson, PhD, expressing strong support for the court’s decision and the FDA’s choice not to pursue further legal action. 

AMP views the outcome as a decisive win for patients, molecular pathologists, and the broader clinical diagnostics field.

AMP shared the following statement on behalf of AMP President Jane S. Gibson, PhD:

“The Association for Molecular Pathology is pleased that the U.S. Food and Drug Administration will not appeal the U.S. District Court’s recent ruling regarding the regulation of laboratory-developed test procedures. This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs.

AMP remains firmly committed to safeguarding the interests of our members and the patients we serve. After a careful and thorough evaluation, we pursued legal action against the FDA out of concern for the serious impact the LDT final rule’s regulatory changes would have had on patient care and the field of molecular pathology. The court’s favorable ruling was a significant victory for patients and healthcare providers across the country.

Moving forward, our members will continue to collaborate with policymakers and key stakeholders to clarify the current CLIA regulations and help shape an effective, efficient and appropriate legislative framework—one that bolsters the clarity provided by the court decision, enhances transparency, fosters innovation, prevents unnecessary cost escalation and ensures broad access to these essential medical services.”