Testing with Confidence: Key Takeaways and Insights

Understanding LDT Final Rule

A May 2024 U.S. Food and Drug Administration final rule declared its intent to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).  The move was intended to bring LDTs under direct FDA oversight, ensuring these tests met the same requirements as other medical devices, including premarket and quality management requirements. This oversight was set to phase in over four years, starting in May of this year.

However, in March, a federal judge in the Eastern District of Texas vacated this final rule, stating the FDA overstepped its authority by attempting to regulate LDTs as medical devices. The court noted LDTs are a professional service, not tangible products, and thus fall outside of FDA jurisdiction. As a result, the FDA’s prior ruling has been vacated and LDTS are not required to comply with its provisions.

So Where do we go From Here?

In the wake of LDT Final Rule, a mixed feeling from the laboratory community is felt. While the final rule’s purpose was in good faith to ensure LDTs were produced with care and patient safety in mind, it also proposed substantial reporting requirements that could create challenges for medical laboratories, especially those not with limited resources to adjust to these changes. Now with the ruling in limbo, some labs may feel uncertain about where to turn, what rules to follow, and how to ethically and safely produce LDTs that are up to standards, even when all have the same goal in mind, quality patient care.

“We're all trying to fill the void but also make sure that we lean into what I think was probably the original purpose of safe and effective lab tests,” explained Dr. Nye.

Moreover, labs are not without resources to help them navigate an uncertain regulatory playing field, nor should they expect to be. Panel experts advised labs they should still follow third-party review guidelines, accepted international standards like CLSI guidance, other requirements set forth by the FDA, and of course, reevaluating working relationships between developer and supplier.

“I do think that the medical device industry and the LDT community have a responsibility to provide increased levels of documentation and support so that laboratories can build their own files and deliver more confidence in what they're providing,” Wijker said. “I think the whole supply chain could take some lessons here as well and then upgrade a little bit.”

Most importantly, labs should remember where the FDA does have authority and continue to be mindful of where LDTs fall within the scope of compliance as a manufacturer.

“The FDA has teeth against manufacturers. The only warning I would give to labs is to be careful with what you incorporate into your tests,” Dr. Stenzel, Retired Director, Office of In Vitro Diagnostics, US FDA, said. “If you're using an Ruo Kit, make sure that you are following the FDA rules and not making clinical claims about the kits. If the FDA is allowed to enforce its ruling, it could again reassert itself.”

“Labs shouldn’t view this as carte blanche to do whatever they want,” Bennett added. “Always make sure that you (lab professionals) are talking with your regulatory experts, your legal counsel. If you’re thinking of doing something a little more ‘outside the box,’ ensure that you’re not tiptoeing into FDA regulated space.”

The Rise of AI in Clinical Labs

Panelists also took on the hot topic of artificial intelligence (AI) and its role and integrity in a laboratory setting. AI has taken many industries by storm. With so much about its capabilities still unknown, questions about the place of AI in laboratory testing and patient care cannot be left unanswered.

The direct impact of AI in patient care is still being modeled and closely examined. Dr. Nye expressed there’s still a learning trajectory with AI, which is an impressionable system evolving over time. But AI, while still developing, isn’t a new concept in laboratory medicine, and has worn many hats over the years.

Dr. Stenzel recalled one of the first ways AI was used in testing. He described an artificial pancreas that monitored a patient’s blood and how it responded to doses of insulin. Based on the AI’s findings and complex calculations, the treatment could be tailored specific to the unique ways the patient would respond to glucose.

Another common use for AI, explained Mario Wijker, is simplifying administrative tasks, like reviewing batch records, a task that can be done quickly and cost effectively with automated algorithms and processing.

“For example, we have used AI to look at difficult non-conformances at a design center or a manufacturing site or corrective and preventive actions where you have a lot of data that you need to analyze,” Wijker said.  “You're not going to put 10 of your high paid researchers or other qualified people in a room for 2 weeks when you have a technology that can do that for you.”

And while AI can be a safe and effective tool, panelists stressed it should still be utilized carefully within certain parameters and only when necessary, when it comes to patient care. Dr. Stenzel emphasized that AI can be used complementarily but should never be used in place of a third-party review. Bennett expressed an AI is only as good as who is programming it.

“Absolutely AI can be trustworthy,” Bennett said. “But I think the converse is equally important. If someone throws together an AI and trains it with very poor-quality data that's not going to be good AI outcomes, and it shouldn't be relied upon without validation.”

Panelists made it clear to participants that AI is a tool but not a substitute, especially when it comes to tasks handled in a laboratory.

“So many laboratory tasks are highly automatable, even the generation of a draft report. But it still requires an intelligent, qualified human at the end, to review the work and sign off on it,” Wijker said.

And a common area of agreement among all panelists about the use of AI was to prioritize patient safety and security and to never put patient information, company data, or other sensitive material into a large-scale open AI platform.

How you can get involved

Missed us April 29? No worries! There’s still time to register for access to the on-demand recordings and listen to compelling discussions from industry leaders and help your lab navigate regulatory change. Live session recordings, tools, polls, and more resources are available.  Register with CLSI to have access to Testing with Confidence panel discussions and learning labs designed to boost your knowledge and readiness.