Loading
A cancer blood test improves every year, but a ten-year trial tests the old version. Regulators and sponsors could agree in advance how updates are validated and carried into the result.
FDA's Predetermined Change Control Plan for AI devices offers a model. Propose an MCED-specific plan: the classifier may be updated on banked baseline samples under locked-test-set rules, each version must be shown non-inferior on a sequestered set, and the primary analysis uses the enrolment version with a pre-specified sensitivity analysis re-scoring banked plasma.
Shares GRAIL, Early detection of cancer, Multi-cancer early detection (MCED), The hardest cancers are found late.
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED), DNA methylation profiling.
Shares PATHFINDER 2, Early detection of cancer, NHS-Galleri, Multi-cancer early detection (MCED).
Shares Early detection of cancer, Multi-cancer early detection (MCED), The hardest cancers are found late.
Shares Early detection of cancer, Multi-cancer early detection (MCED), DNA methylation profiling, The hardest cancers are found late.
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED), The hardest cancers are found late.
Shares PATHFINDER 2, NHS-Galleri, Multi-cancer early detection (MCED).
Shares Early detection of cancer, Multi-cancer early detection (MCED), The hardest cancers are found late.