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Laboratory Developed Tests

February 17, 2021

Laboratory Developed Tests
Presented by Thomas C. King, MD, PhD, Medical Director
Published February 17, 2021

Dr Tom King, Medical Director at Immunovia Inc, presents Laboratory Developed Tests, their definition, regulation, and accreditation.

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