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. 

MRN Launches PreDict Product Development Service Offering

Medical Research Networx, LLC launches PreDict Product Development Service offering. MRN will now offer scalable services ranging from the design and development of assays to commercially-ready laboratory developed tests (LDT) or FDA cleared kits under a complete Quality System. Through MRN’s commercial partners, MRN can offer FDA-audited cGMP facilities for contract manufacturing. MRN’s preferred clinical sites are CLIA/NYS accredited labs within leading university centers, within globally recognized centers of excellence.

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