The Future of Laboratory-Developed Tests in Hemostasis Laboratories

Abstract

Laboratory-developed tests (LDTs) are widely used in clinical hemostasis laboratories. The extent to which LDTs are regulated varies greatly around the world, and proposed changes to regulations have raised concerns about the future of LDTs in clinical laboratories. It is increasingly difficult to justify the use of an LDT where a commercially available method with regulatory approval is available. Conversely, where there is no suitable test with regulatory approval and there is a compelling clinical need, using an LDT outweighs the risk associated with not performing the test. We argue that LDTs are still required in specialist clinical laboratories to fulfill unmet clinical needs, and in lower middle-income countries where they are a vital resource.

Laboratory Diagnostics for Thrombosis and Hemostasis Testing—Part II

“…The next article in this issue, from Gardiner et al, delves into the discussion of laboratory developed tests (LDTs), assays that are more commonly performed in highly specialized hemostasis/thrombosis laboratories, and that fill an important niche for patient testing when there are no commercially available options approved by local regulatory authorities, or the commercial options are of substandard quality. 7 The manuscript provides important background context on differences in laboratory regulation in different parts of the world, and explores the challenges associated with increasing LDT regulation with potential impacts to patient care. The manuscript provides helpful tables that summarize studies that should be performed during the validation of a high-quality LDT.…”