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Peer-reviewedCC BYJournal of mass spectrometry and advances in the clinical lab

LDTs in Flux: Will Evolving Regulations Enhance or Complicate Laboratory Practices?

  • Alejandro R Molinelli1
  • Dennis J Dietzen2
  • Jonathan R Genzen3,4
  • Xander M R van Wijk5
  • Maria Alice V Willrich6
  • Melissa M Budelier7,8
8 affiliations
  1. 1Department of Pharmacy and Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, TN, United States.
  2. 2Phoenix Children's Hospital, University of Arizona College of Medicine, Phoenix, AZ, United States.
  3. 3Department of Pathology, University of Utah, Salt Lake City, UT, United States.
  4. 4ARUP Laboratories, Salt Lake City, UT, United States.
  5. 5Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, United States.
  6. 6Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States.
  7. 7TriCore Reference Laboratories, Albuquerque, NM, United States.
  8. 8Department of Pathology, University of New Mexico, Albuquerque, NM, United States.
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Abstract

Clinical labs help diagnose and manage disease by testing blood and other specimens. They operate under federal rules known as Clinical Laboratory Improvement Amendments (CLIA). Most tests are FDA cleared/approved, but some are laboratory-developed tests (LDTs) created in individual labs, typically to meet unmet needs. LDTs have long existed in a complicated regulatory space. In 2024, the FDA issued a rule to regulate LDTs like devices, prompting concerns about cost, innovation, and access. A federal court struck the rule down in 2025, finding LDTs are services, not devices. The FDA subsequently rescinded its rule. In this article, experts argue that LDTs are essential and already held to strong standards and that future reforms should strengthen CLIA while protecting access and innovation.

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Cite

BibTeXRIS
BibTeX
@article{molinelli2026ldts,
  title = {{LDTs in Flux: Will Evolving Regulations Enhance or Complicate Laboratory Practices?}},
  author = {Alejandro R Molinelli and Dennis J Dietzen and Jonathan R Genzen and Xander M R van Wijk and Maria Alice V Willrich and Melissa M Budelier},
  journal = {Journal of mass spectrometry and advances in the clinical lab},
  year = {2026},
  month = jul,
  doi = {10.21627/ggcs2a65},
  url = {https://europepmc.org/article/MED/43011518},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - LDTs in Flux: Will Evolving Regulations Enhance or Complicate Laboratory Practices?
AU  - Alejandro R Molinelli
AU  - Dennis J Dietzen
AU  - Jonathan R Genzen
AU  - Xander M R van Wijk
AU  - Maria Alice V Willrich
AU  - Melissa M Budelier
PY  - 2026
DA  - 2026/07/06
JO  - Journal of mass spectrometry and advances in the clinical lab
DO  - 10.21627/ggcs2a65
UR  - https://europepmc.org/article/MED/43011518
AB  - Clinical labs help diagnose and manage disease by testing blood and other specimens. They operate under federal rules known as Clinical Laboratory Improvement Amendments (CLIA). Most tests are FDA cleared/approved, but some are laboratory-developed tests (LDTs) created in individual labs, typically to meet unmet needs. LDTs have long existed in a complicated regulatory space. In 2024, the FDA issued a rule to regulate LDTs like devices, prompting concerns about cost, innovation, and access. A federal court struck the rule down in 2025, finding LDTs are services, not devices. The FDA subsequently rescinded its rule. In this article, experts argue that LDTs are essential and already held to strong standards and that future reforms should strengthen CLIA while protecting access and innovation.
SN  - 2667-1468
SN  - 2667-145X
ER  -