The FDA Backpedals on LDTs: What It Means for Clinical Labs
For more than a decade, labs have operated under a cloud of uncertainty around who truly regulates laboratory developed tests (LDTs). The FDA’s now-rescinded 2024 final rule would have classified LDTs as medical devices, forcing hospital and health system labs into an additional layer of oversight. That rule has now been vacated, and with this week’s action, the FDA has formally stepped aside.
This is not just a legal technicality. For many labs, the threat of dual regulation created real hesitation to develop or maintain LDTs. Smaller programs in particular faced the possibility of abandoning safe, effective tests that patients rely on. With FDA stepping back, enforcement authority for LDTs rests where it belongs, under CLIA.
That clarity matters. CLIA has always been the framework guiding how labs design, validate, and maintain their own tests. It recognizes that LDTs are built for the unique needs of each lab’s patient population. And it empowers directors and staff to innovate responsibly without duplicative burdens that stifle progress.
At Bitscopic, we live in this space every day. Our PraediGene platform exists to help CLIA-certified labs build and validate genomics LDTs that meet rigorous standards while delivering actionable insights for clinicians. Whether in pharmacogenomics or oncology, our role is to reduce complexity, streamline compliance, and shorten the path from raw sequencing data to decision-ready reports.
PraediGene is Trusted by Veterans Affairs National Reference Labs
If your lab is developing new LDTs, let us show you how PraediGene can help you reduce risk, gain speed, and scale your program (without having to scale your team).