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The Future of Laboratory-Developed Tests in Hemostasis Laboratories
Chris Gardiner1, Marión Echenagucia2, Robert C Gosselin3
1Specialist Laboratory Medicine, St James University Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Seminars in Thrombosis and Hemostasis
|January 5, 2023
Summary
Laboratory-developed tests (LDTs) remain crucial for clinical hemostasis labs, especially when no approved alternatives exist or in lower-income nations. Their use is justified by unmet clinical needs, balancing risks against diagnostic necessity.
Area of Science:
- Clinical diagnostics
- Laboratory medicine
- Hemostasis testing
Background:
- Laboratory-developed tests (LDTs) are integral to clinical hemostasis laboratories.
- Global regulation of LDTs varies significantly, with proposed changes causing uncertainty.
- The availability of commercially approved tests challenges the justification for LDTs.
Purpose of the Study:
- To evaluate the continued necessity and justification of LDTs in clinical settings.
- To address concerns regarding the future of LDTs amidst evolving regulatory landscapes.
- To highlight the role of LDTs in addressing unmet clinical needs and resource limitations.
Main Methods:
- Review of current regulatory environments for LDTs worldwide.
- Analysis of the clinical utility and necessity of LDTs versus approved alternatives.
- Case-based assessment of LDT use in specialist and resource-limited settings.
Main Results:
- LDTs are increasingly difficult to justify when regulatory-approved alternatives are available.
- LDTs remain essential where no suitable approved test exists and a clinical need is compelling.
- LDTs are vital in specialist laboratories for unmet needs and crucial in lower-middle-income countries.
Conclusions:
- LDTs continue to be required in specialized clinical laboratories to meet specific patient needs.
- The use of LDTs is justified when they address critical diagnostic gaps not covered by approved tests.
- LDTs serve as an indispensable resource in lower-middle-income countries for essential diagnostic services.
