Concept实验室自建检测 / Laboratory Developed Tests
LDT
A diagnostic test developed by a laboratory and used within that laboratory, long subject in the United States to a relatively permissive regulatory pathway that allowed clinical use without premarket FDA approval; Theranos exploited this regulatory gray area.
Timeline (last 90 days)
Sep 9
Theranos exploited the regulatory exemption for laboratory-developed tests (LDTs), packaging its commercialized blood testing services as LDTs to bypass FDA approval.
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