Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more
Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more