Laboratory developed tests (LDTs) for in vitro diagnostics can be developed and ready for use more quickly than traditional diagnostic tests, while still being accurate and reliable.
In this white paper, the authors describe regulatory considerations for LDTs and key factors for successfully developing and using LDTs in clinical trials. Input provided by:
- Palanikumar Manoharan, Ph.D.
Principal scientist, Central Lab, PPD® Laboratory services, a part of Thermo Fisher Scientific
- Josh Basford, M.S.
Senior research scientist, Central Lab, PPD® Laboratory services, a part of Thermo Fisher Scientific