Clinical Laboratory Industry Files Lawsuit to Halt FDA’s Implementation of New Regulations on Lab-Developed Tests

The trade association representing laboratory companies and test manufacturers in the United States has filed a lawsuit aiming to prevent the FDA from expanding its oversight of lab-developed tests. The American Clinical Laboratory Association argues that the FDA exceeded its authority by proposing to regulate all in vitro diagnostics with a framework similar to that used for medical devices.

According to the lawsuit, filed in federal court in East Texas, the ACLA contends that subjecting lab-developed tests to the FDA’s product review procedures would impose a burdensome regulatory regime. This, they argue, would significantly escalate research and development costs, impede crucial medical innovation, and hinder the adaptation of existing tests to meet evolving patient needs.

The FDA’s final rule, announced in April after proposing changes last fall, aims to ensure the accuracy and safety of diagnostic tests across the nation, irrespective of whether they are developed by large-scale manufacturers or smaller laboratories. While the FDA previously allowed many lab-developed tests (LDTs) to be used in patient care without prior review, the agency now asserts that advancements in technology and wider usage necessitate increased oversight.

Under the FDA’s rule, certain newly developed or significantly modified tests would face review requirements over the next four years, with exemptions for tests already on the market and certain uses, such as those conducted within a single health system or cleared by New York State’s evaluation program.

The ACLA’s lawsuit argues that LDTs should be considered services rather than individual products, and thus fall outside the FDA’s jurisdiction. They contend that diagnostic results rely on the professional judgment of trained laboratory workers and involve a series of processes and tasks undertaken by these professionals.

ACLA President Susan Van Meter emphasized that the FDA’s rule represents regulatory overreach and would have detrimental effects on the healthcare system, including millions of patients who rely on essential clinical testing services. Instead, the ACLA suggests that any increase in FDA oversight should be addressed through congressional legislation, as testing services are already regulated under the Clinical Laboratory Improvement Amendments (CLIA).

The lawsuit has garnered support from prominent figures in the laboratory industry, including declarations of support from leaders of companies like Labcorp and Quest Diagnostics. These industry leaders argue that seeking FDA approval for every test would be financially unfeasible for many laboratories, and that the FDA lacks the resources to efficiently review the vast number of new diagnostic submissions.