May 30, 2025, marked a pivotal moment in the decades-long journey over the regulation of laboratory developed tests (LDTs) – the federal government declined to appeal the US District Court ruling that vacated the FDA’s controversial Final Rule seeking to impose sweeping oversight over LDTs.
It was a turning point not only for the medical laboratory, but for every patient who relies on us for timely, accurate, and accessible testing. This victory was hard fought for and hard won. It didn’t happen overnight and, at times, it didn’t seem possible. Rather, this victory was earned through our persistent, thoughtful, patient-centered advocacy.
For more than a decade, ASCP has stood at the forefront of the LDT debate. Long before the FDA’s Final Rule, we recognized that regulatory decisions around LDTs would have profound consequences for patients, laboratories, and the entire healthcare system. We knew that these policies could limit patient access to life-saving diagnostics and grind innovation to a halt. The guiding principle of our organization, in everything we do, is patients first, and our fight against the overreach of the FDA oversight of LDTs was no exception.
When the FDA published its Final Rule, which would have dramatically expanded the agency’s oversight over LDTs, we knew action was necessary. ASCP filed an amicus curiae brief in the landmark case that ultimately brought this rule down. Judge Sean D. Jordan’s ruling not only struck down the rule – it reaffirmed what ASCP and much of the laboratory community have been saying for years: FDA does not have statutory authority to regulate LDTs. This ruling didn’t just reject a flawed rule – it affirmed a regulatory structure that is both rigorous and fit-for-purpose. CLIA has long required laboratories to meet strict performance standards when introducing LDTs. These requirements ensure analytical validity and uphold high-quality testing standards, all without impeding innovation or patient access.
In short: the system works. And thanks to this legal victory, it will continue to work.
I want to reiterate that we claimed this victory because we showed up. We advocated for our profession, and importantly, for our patients. And it wasn’t just ASCP as an organization, but our community – pathologists, laboratory professionals, educators, and patient advocates. We were #StrongerTogether and made sure people understood what was at stake.
This moment is a testament to the power of expert-led, patient-focused advocacy. It proves that when we organize, educate, and persist, we can influence the highest levels of government in defense of science, care, and equity. At ASCP, we’re proud to have done the hard work, and proud that it paid off for the betterment of patients. We remain committed to ensuring the voice of the laboratory is heard – clearly, consistently, and with purpose.
Because when the laboratory wins, patients win. And we’re just getting started.
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