Laboratory Developed Tests

februari 17, 2021

Laboratory Developed Tests
Presenterad av Thomas C. King, MD, PhD, Medical Director

0:00 Definition of laboratory developed tests (LDT)
0:24 LDT is usually faster than FDA to provide access to clinical diagnostics
0:38 Regulation of LDTs
1:23 Burden of development rests with the laboratory
1:36 Example: Next Generation Sequencing in the US is done as LDT
1:54 Process for CLIA licensure
2:45 The start of patient testing
3:14 CAP accreditation, the gold standard for Laboratory Quality in the US
4:24 Summary