OnCo
ideasIdea

Mandatory interval-cancer audit for every blood-based screening test

When a screening test misses a cancer, we should know. Linking every negative result to the cancer registry and publishing what was missed, by stage, should be a condition of use.

Cervical and breast programmes audit interval cancers routinely; commercial blood tests do not. Propose that authorisation or reimbursement for MCED and single-cancer blood tests requires registry linkage of all negatives, with annual publication of stage-specific sensitivity, interval cancer rates, and test-negative cancers by subtype.

Hypothesis
Registry-linked audit will reveal real-world stage I sensitivity materially below case-control estimates for at least some cancers, and will change which tests payers cover.
Rationale
Case-control designs overstate sensitivity through spectrum bias; only prospective negatives tell the truth. The audit is cheap where registries exist.
What would test it
Pilot with one approved test (e.g. Shield for colorectal cancer) in a state with a complete registry; publish the two-year interval cancer rate.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks

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