What does the FDA’s final rule on LDTs change? The rule makes it explicit that in vitro diagnostics (IVDs) that are manufactured by clinical laboratories—i.e., laboratory-developed tests (LDTs)—are considered devices under the Federal Food, Drug, and Cosmetic Act (FDCA). IVDs are tests performed on samples such as blood or tissue that have been taken from the human body. LDTs are ...
The Conversation: AI can design and run thousands of lab experiments without human hands. Humanity isn’t ready for the new risks this brings to biology
AI can design and run thousands of lab experiments without human hands. Humanity isn’t ready for the new risks this brings to biology
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