Greer Massey, PhD, chief scientific officer at Molecular Designs, shares insights on how labs are affected by the rule’s reversal and how they can prepare for future regulatory changes.
The US Food and Drug Administration (FDA) announced its intent to rescind its final rule that would have extended regulatory oversight to laboratory developed tests (LDTs), following a federal court decision earlier this year that vacated the regulation.
The rule, published in May 2024, would have required laboratories to comply with additional medical device requirements, potentially delaying test development and driving up costs.
In this Q&A, Greer Massey, PhD, chief scientific officer at Molecular Designs, discusses what the proposed regulations could have meant for innovation, smaller labs, and testing timelines—and shares insights on how laboratories can navigate regulatory uncertainty and prepare for possible future changes.
Most healthcare organizations were against the FDA’s recently vacated LDT regulations. If they had gone forward, what would have been the implications for clinical labs?
If a federal judge in Texas had not blocked the FDA’s proposed additional oversight of LDTs in March 2025, meeting these stricter standards would have added up to two years to test development timelines. As you point out, many in the industry were against these additional standards, perceiving the agency’s proposal as over-regulation.
The additional FDA criteria also would have increased expenses, decreased responsiveness to public health needs, and impeded innovation. As the COVID-19 and Mpox outbreaks taught us, we cannot afford to wait years to develop a test during a public health emergency.
The additional oversight would have created difficult decisions for lab directors. Some leaders would have had to reallocate resources designated for innovation toward continued survival of their laboratory’s business.
Regulations governing safety and above-board operations are certainly necessary. How do we make sure that the LDT framework keeps up with advances in clinical technology?
No one is saying that LDTs should not be regulated. However, long-standing, robust, and science-backed regulation under the Clinical Laboratory Improvement Amendments (CLIA) and the use of accrediting organizations like Commission on Office Laboratory Accreditation (COLA) and College of American Pathologists already ensure optimal quality for LDTs and training of laboratory staff. These organizations update their regulations periodically as advances in research and clinical technology dictate.
The FDA’s LDT regulations reflect the political uncertainties that seem to have become common today. Considering that another administration could make massive changes in increasing regulations, while a following one could ease them substantially, what should labs do to guard against political uncertainty? Is flexibility the only answer or something else?
Flexibility is important but so is preparation. Laboratories should focus beyond minimum quality requirements to anticipate and plan for any upcoming regulatory changes. The details of government and industry oversight can change at any time. Remaining proactive and informed helps safeguard against the disruptions due to regulatory back-and-forth in the future.
It seems the biggest beneficiaries of the reversal of the LDT regulations were small labs. Is that the case? And why is it important that we have smaller players remain competitive in the market?
Smaller labs tend to be more agile, in general, than the large industry players. This flexibility allows smaller labs to pivot and react faster to emerging infectious disease pathogens. LDTs produced by these labs can be created or modified rapidly as new variants of concern start circulating. Also, many times smaller labs need to be creative to compete with the larger players, which can drive innovation.
Had the Texas judge allowed the FDA regulations to go into effect, smaller or medium-sized labs might have had no choice but to forgo production of specific tests. This move would have limited the ability for researchers to detect rarer conditions or to support an effective antibiotic stewardship program, for example.
Labs of all sizes benefit from the reversal of the LDT regulations but especially smaller organizations with fewer resources, for which the additional regulations and requirements could have been more onerous to meet. Market competition is beneficial to spur innovation and keep prices competitive, and laboratory testing is no exception.
What does the LDT landscape look like to you over the next five to 10 years?
For now, it’s a return to business as usual, staying agile, developing new high-quality LDTs as needed, and operating under CLIA and COLA regulations. The future is never certain, but there are concrete steps laboratories can take now to minimize any disruption from future changes.
For example, conduct regular internal reviews rather than waiting for a future surprise audit. No laboratory director wants to have to respond to an unanticipated audit. It’s better to be proactive and make every effort possible to meet quality and consistency standards.
Also lead by example. It is likely that the conversation about LDT regulation is not over. In the meantime, laboratory leaders and staff should continue to be driven by data, bound by existing rigorous standards, and focused on improving the quality of LDTs for decades to come.
