In March 2025, the US District Court for the Eastern District of Texas struck down the FDA’s final rule to regulate laboratory developed tests (LDTs) as medical devices. Many in laboratory medicine greeted the decision with relief. The ruling was hailed as a win for innovation and laboratory autonomy, and a safeguard for patient access – especially for rare disease testing and rapidly evolving diagnostics.
But amid the celebration, I find myself asking a different question: Did we really win?
The answer isn’t simple; while the ruling may have deferred regulatory oversight, it did nothing to resolve the persistent unmet need in laboratory medicine: standardization. And the reality is, for all our insistence on scientific rigor, standardization remains one of our field’s biggest blind spots – particularly in the very category of tests most affected by this ruling.
The fight is not over
First, let’s be clear: this story isn’t finished. The FDA will most likely appeal the decision, and the legal status of LDT oversight is anything but settled. While the court’s decision may have paused federal enforcement, it didn’t eliminate the underlying regulatory tension. If anything, it has simply transferred responsibility back to us – the practitioners and stewards of diagnostic testing – to answer a pressing question:
If not the FDA, then who?
A question of proficiency
Over the last 50 years, technology has rapidly progressed; unlike the era when the FDA originally enacted enforcement discretion, it is no longer the case that laboratories develop simple diagnostic tests with limited impact. Today, even the staunchest critics of FDA regulation will acknowledge that quality among LDTs can vary widely. Proficiency testing (PT) programs exist, but they’re inconsistent and limited in scope. In many areas of molecular diagnostics – the posterchild of the LDT world – proficiency testing is still rudimentary.
Let’s take an example from transfusion medicine: molecular identification of red blood cell antigen alleles. While these tests are becoming more widely used, PT in this space is extremely limited in the US. Most programs evaluate only a handful of common alleles, and some molecular platforms have no structured oversight at all. This leaves substantial gaps in both accuracy and accountability.
And that’s just one subspecialty. Across laboratory medicine – especially in genomics, epigenetics, and next-generation sequencing – the landscape is increasingly fragmented. Validation methods vary. Reporting standards differ. Interpretation frameworks diverge. The absence of a shared regulatory baseline means patients may receive very different results, depending entirely on where their sample is tested.
What was the FDA really trying to do?
It’s easy to cast the FDA as a bureaucratic obstacle. In reality, the agency was attempting to extend the same safety and quality principles that govern other medical devices to laboratory developed tests – many of which now directly inform critical clinical decision making. If we accept the possibility that patients and clinicians are receiving different results from different labs, then we must face a new aspect of health inequity – one that we as diagnostic stewards are responsible for.
Was the proposed rule perfect? No. Implementation would have been burdensome for some laboratories, especially smaller institutions and those operating on lean resources. But the intent behind the rule was not malicious. It was a response to the increasing complexity, reach, and clinical significance of LDTs in modern medicine. For some laboratories that did not intend to market their tests beyond their local patient population, the rule would have been essentially equivalent to existing CLIA regulations.
In other words: the FDA wasn’t trying to stifle innovation. It was trying to ensure patients receive accurate, reproducible, and safe testing – no matter where they are.
What we gained – and what we might have lost
To be sure, the court’s decision preserves some breathing room. Smaller labs and academic institutions retain the ability to develop and deploy niche tests without the financial and logistical hurdles of FDA approval. That flexibility matters – especially in rare disease research and rapidly evolving infectious threats.
But we must also be honest about what we lost.
We lost a national framework for standardization. We lost an opportunity to formalize quality benchmarks across platforms and institutions, with external assurance that we are doing the best for our patients. We lost a potential lever for aligning diagnostics with the broader culture of patient safety that governs other medical devices and therapeutics.
And perhaps most dangerously, we risk reinforcing the idea that autonomy and accountability are mutually exclusive.
If we resist external regulation, the burden is ours
If we celebrate the rejection of FDA oversight, we must be willing to take up the work ourselves.
That means:
Expanding and strengthening proficiency testing programs, especially in molecular and genomics-based assays.
Encouraging cross-institutional collaboration on validation protocols and reference materials.
Pressuring professional societies to define and disseminate best practices with weight – not just recommendations, but expectations possibly linked to accreditation.
Investing in quality infrastructure, even when no one is forcing us to.
Because, if we want the freedom to innovate, we must also own the responsibility to regulate ourselves.
It wasn’t a victory – it was a warning
The court’s decision wasn’t the end of the conversation. It was the start of a challenge.
The legalities may have delayed regulatory oversight, but don’t change the fact that patients deserve consistency, transparency, and quality – no matter who is holding the clipboard or writing the result. The question now is whether the field of laboratory medicine is ready to step up.
If we want to preserve our autonomy, we have to earn it. That means acknowledging the gaps, investing in the solutions, and leading the movement toward internal standardization – before someone else comes back to do it for us.
Because in the end, it’s not just about regulatory burden or institutional control.
It’s about patient care.
And it’s on us.
Caitlin Raymond is a clinical fellow at the National Institutes of Health, USA
Special thanks to Wade Atkins at the National Institutes of Health for his thoughtful feedback on this piece.
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