FEATURE
Pathologists ( CAP ) -accredited laboratory , a final review by the CLIA / CAP laboratory director occurs before any clinical inpatient testing .
“ It ’ s a very prescriptive process ,” Lange said . “ We are validating a methodology in conjunction with a test system to meet a need .”
After a method has been published , LDTs in Orsini ’ s laboratory undergo rigorous testing of how well the method works , he said . LDTs are formally validated using guidelines from New York State ’ s Clinical Laboratory Evaluation Program ( CLEP ).
The new FDA rule for LDTs states that a laboratory with a New York State permit , qualified director , and LDTs reviewed and approved by CLEP will not be required to have their LDTs reviewed by the FDA , according to Orsini . Yet as a whole , New York ’ s public health reference laboratory and other clinical laboratories regulated by the CLEP system must meet other requirements as FDA ’ s policy is phased in over the next four years , he said . “ The Wadsworth Center is currently reviewing the new rule to identify areas that may be impacted ,” Orsini said .
Lange said she expects the new FDA rule to mean the end of some LDTs used at WSLH . Adhering to the new requirements will increase the need for resources , such as additional staffing , computer systems and legal consultation .
“ Due to the financial constraints of being a state public health laboratory , this is stopping our implementation of new LDTs ,” she said . “ In fact , we also have a timeline to take down LDTs as the ruling is limiting our ability to plan for and respond to future needs . We will have to adapt and adjust with what we have since we have no funding to support additional resources to meet these FDA requirements .”
Cost is a critical part of the conversation about how the FDA rule may affect public health laboratories , according to Mandi Cosser , MPH , manager , regulatory and public policy for APHL . The cost burden is intensified in laboratories making modifications to FDA-approved tests , which then become classified as LDTs . “ Public health laboratories have such
How we support innovation in laboratory testing may have to shift . We may become advisors to industry rather than the doers who can quickly stand up and meet the needs of the communities we serve .”
Meshel Lange , MS
limited operating budgets , and every dollar counts ,” she said .
In addition to increasing costs , Lange said she also expects the new rule to affect innovation .
“ How we support innovation in laboratory testing may have to shift ,” she said . “ We may become advisors to industry rather than the doers who can quickly stand up and meet the needs of the communities we serve .”
Lange said the rule may also have a longer-term impact on the public health laboratory workforce — one that may place public health in an uncompetitive position with industry .
“ We have a lot of talented staff that want to work in emergency preparedness and response ,” she said . “ You get to be that novel method development chemist , QA officer or response chemist that ’ s actively helping to meet needs we see . That ’ s a unique role . There ’ s a potential for loss of talent , which has been a critical issue for public health laboratories across the country .”
Flexibility — But How Much ?
Levinson said LDTs provide her laboratories with flexibility . “ We use LDTs not only to meet emerging and other public health needs , but also to tailor our testing to the needs of our state and of the population within our state ,” she said .
LDTs come in many flavors , she added . An LDT may be a modification to an existing FDA-approved test or a test that has been fully developed in the laboratory — or something in between . As an example , Levinson cited a test that may have been approved by FDA but not for a pediatric population . That ’ s where the flexibility of LDTs matters , she said .
“ We can bring on this test and validate it for that population ,” Levinson said . “ It would be an LDT , but we could still meet the needs of pediatric patients . That ’ s the kind of flexibility I see us needing to retain . If we ’ re not able to do that and can ’ t offer that testing , we ’ re not meeting the needs of our clinicians and of Tennesseans .”
When asked how the FDA rule could affect the flexibility to modify existing tests , Levinson said , “ A lot of it is unknown , and that ’ s causing concern and anxiety for myself and my team . Broadly speaking , in talking with colleagues , there ’ s certainly potential for this LDT rule to slow our ability and our speed to respond to urgent or novel public health needs if we now have to submit tests for approval .”
Some enforcement discretion will continue to be allowed under the FDA rule , potentially providing relief . “ I consider that a huge win because that would have a drastic negative effect on laboratories if we didn ’ t have that flexibility built in ,” Levinson said .
Historically , enforcement discretion and laboratory director approval allowed LDT development to move quickly in response to urgent needs . Levinson noted the inclusion of a carve-out in the final rule for immediate response .
“ We ’ ve seen that come into play already with H5N1 for avian influenza ,” she said . “ My concern is about the unknown and trying to predict how FDA will actually employ this for future emergent needs , at what scale and how much flexibility we ’ re going to retain .”
How Public Health Laboratories Are Adapting
Amid the uncertainty of some unanswered questions — particularly around LDTs involving toxicology — public health laboratories are preparing to meet the May 6 , 2025 , deadline for complying with the first stage of the new FDA rule .
PublicHealthLabs @ APHL @ APHL . org . org APHL . org
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