Clinical lab industry sues to block FDA's new oversight of lab-developed tests

The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its authority when it announced it would regulate all in vitro diagnostics with largely the same approach it uses for medical devices.

In its lawsuit (PDF), filed this week in East Texas federal court, the American Clinical Laboratory Association said applying the FDA’s product review procedures would bring an “onerous regulatory regime” that would “dramatically increase research and development costs, hinder vital medical innovation, and hamper adaptation of existing tests to meet evolving patient needs.”

After proposing the long-awaited changes last fall, the agency published its final rule at the end of April, saying it was necessary to ensure the accuracy and safety of the nation’s diagnostic tests regardless of whether they were developed by a high-volume manufacturer or a comparatively smaller laboratory.

For decades, the FDA had allowed many lab-developed tests, or LDTs, to be used in patient care without prior review. They were originally deemed to have fewer risks compared to mass-marketed diagnostics, being used on a smaller scale and performed on common lab equipment.

However, the FDA described today’s LDTs as reaching much wider populations and employing newer technologies—with their results being relied upon to guide cancer treatments, screen newborns or diagnose diseases such as Alzheimer’s. The agency has also said that many developers have treated LDTs as a way to soft launch their products before subjecting them to federal review.

The FDA’s rule would phase in review requirements for some newly developed or significantly modified tests over the next four years while grandfathering in diagnostics already on the market and offering exemptions for certain uses—such as LDTs that are performed by a lab integrated directly within a single health system. Tests that clear New York State’s evaluation program would also not require an FDA stamp of approval.

The ACLA, meanwhile, posits that LDTs aren’t individual products, but services—and therefore outside the FDA’s purview.

In its complaint, which was joined by the Texas-based infectious disease test provider HealthTrackRx, the trade group said that interpreting and delivering diagnostic results depends upon the professional judgment of trained lab workers.

As an example, the lawsuit describes the steps of using a mass spectrometer to identify certain protein levels in a patient’s blood—including preparing reagents, loading the samples into the machine and reviewing the accuracy of the results.

“This is a laboratory-developed testing service: a series of processes and tasks undertaken by trained laboratory professionals using instruments and other tools to derive information that may be useful to a treating physician,” they said.

“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” ACLA President Susan Van Meter said in a statement. “These professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve. The Rule will disrupt this 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.”

Instead, ACLA said that new congressional legislation should be the only method to increase the FDA’s oversight of LDTs, and that testing services are already regulated under the Clinical Laboratory Improvement Amendments, commonly known as CLIA.

ACLA’s membership counts testing providers such as Labcorp and Quest Diagnostics—whose leadership filed declarations of support alongside the lawsuit—as well as diagnostic developers and lab equipment manufacturers.

Labcorp's chief scientific officer, Marcia Eisenberg, said that many lab companies would not be able to afford to seek FDA green lights for every test on their menus—while Quest's chief medical officer, Yuri Fesko, said the agency currently lacks the resources to timely review potentially thousands of new diagnostic submissions.