CLN Daily 2024
The FDA’s new ruling on laboratory developed tests (LDTs) is set to change the way clinical laboratories operate when it comes to making and validating their own tests. While the ruling doesn’t take effect until May 6, 2027, and could change if there are amendments, FDA-issued clarifications, legislation, and clinical laboratorians need to be prepared for what will be a major shift in the field.
“It’s the largest change to lab regulation since the beginning of CLIA,” said Stephen Master, MD, PhD, FADLM, division chief for laboratory medicine at Children’s Hospital of Philadelphia. During a special session, Operationalizing Changes to LDT Oversight: Building Roadmaps When the Rubber Hits the Road, taking place on Tuesday, July 30 at ADLM 2024, Dr. Master will participate in a panel discussion alongside Jonathan Genzen, MD, PhD, Eric Konnick, MD, and moderator Mark Marzinke, PhD, DABCC FADLM, AMOC chair, to discuss how these challenges will affect ADLM members' ability to provide quality patient care. Attendees will also hear from a caregiver and patient advocate on their perspective on the importance of LDTs in diagnosing medical conditions.
The likelihood that this legislation will impact laboratory practice and business is unavoidable. This will be especially true for smaller labs, said Master, who have previously created tests that could be used outside of just their circle. “Labs need to be considering whether those tests are only going to serve their own hospital population, or if they had intended for those to serve a larger, broader regional group.” If the former, they shouldn’t be affected by the rule. But if the latter? As of how the rule stands at the time of this publication, they will have to undergo the FDA burden of regulation, “and that may cause some labs to decide not to perform certain tests.”
Medium sized labs could be affected because the rule will call into question whether they should be making investments in LDTs because other labs could come up with an FDA-approved test that would supplant theirs. For large laboratories that want to “continue to be on the forefront of diagnostics, they’re going to have to invest fairly extensively,” Master said.
The ruling could also harm children with rare diseases because children’s hospitals have “long relied on the fact that there would be one or two hospitals that would come up with a test for rare diseases,” he said. “There’s no money in that, but it is done as a service to the community.” Under this ruling, those tests would also need to be approved by the FDA, or only be used on their own patients.
While the FDA said the rule is final, it hasn’t been out long, and there are still details that need to be ironed out. This session was chosen for ADLM 2024 in October of 2023, he added, and things have already changed drastically since then.
As such, the best way to move forward is together. “A lot of us in the laboratory community are still trying to understand a) what the rule says, and b) what the implications are,” Master said, which is why he sees this panel as critical. “The more we put our heads together as a community and share information, the better chances we have in successfully navigating these decisions.”
According to Master, the best place to find the most current information will be at the special session. “Everyone should know this is a moving target and it’s likely that there may be new information by the time attendees arrive in Chicago,” he said. “It’s a fluid situation and the more we learn quickly, the better.”
While 3 years may seem like a long time ahead, working through the knots is critical right now for multiple reasons, including cost. “There are certain things we need to be changing today so that 3 years from now, we don’t find ourselves in a difficult or expensive situation,” he said.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +X: @byJenAMiller.