Tumour-informed versus tumour-naive ctDNA assays
A tumour-informed blood test is built for one patient: the tumour is sequenced first and the test then hunts for that patient's own mutations in blood. A tumour-naive test uses the same fixed panel, often of methylation marks, for everyone, so it needs no tumour sample and returns faster.
Overview
Tumour-informed assays (Signatera, RaDaR) sequence the resected tumour, choose a set of clonal mutations, and track them in plasma at high depth, which gives high specificity and lets a positive be called on very few molecules; the cost is a tumour sample, a bespoke panel per patient and a longer first turnaround. Tumour-naive assays (Guardant Reveal and most multi-cancer tests) apply a fixed panel of mutations and methylation or fragmentation features to every sample, so they work without tissue and from the first draw, at the price of having to distinguish tumour signal from clonal haematopoiesis and other background. Trials so far have used tumour-informed tests for treatment decisions (DYNAMIC used a tumour-informed approach; IMvigor011 used Signatera), while screening tests are necessarily tumour-naive. Head-to-head sensitivity comparisons are few, and results are not interchangeable between assays.
- Plasma
- Tumour-informed variants at < 0.01%
- Serial draws after surgery
Showing the technology this term belongs to: MRD / molecular residual disease testing.
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