Hot IVD Topics

FDA Regulation of Laboratory Developed Tests

Laboratory Developed Tests (LDTs) include tests developed within a clinical laboratory, and offered directly to physicians through that laboratory.  Prior to 2004, these tests were of limited scope and typically offered to local or institutional physicians only. However, starting roughly ten years ago, LDTs have been offered more broadly by clinical laboratories, including commercial labs attached to medical device developers.  These now include companion diagnostics and molecular diagnostic assays, and available LDTs number in the thousands. 

Using Remnant Biospecimens In Medical Research

Remnant biospecimens:  What biospecimens are encompassed under the “remnant” umbrella, and what are the legal, moral and appropriate applications of remnant biospecimens?

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