Loading
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.
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.
Showing the technology this term belongs to: MRD / molecular residual disease testing.
The glossary entry explains the word; the readout page carries the scoring rule, the thresholds approvals use, the companion diagnostics and the tests.
Residual-disease testing may not need the tumour to be sequenced first, which would remove the slowest step of tumour-informed assays; the comparison with tumour-informed results in the same patients is the evidence that matters.
Residual disease testing is prognostic after EGFR lung cancer surgery, but in this trial it did not pick out who benefits from icotinib, since both groups did.
Enrichment may make parts-per-million testing possible on small sequencers, though only eight patients were studied.
At these levels the honest unit is a count of molecules, not an allele fraction, which is the counting limit behind attributing residual disease to a clone.
Surveillance blood tests in hormone-receptor-positive breast cancer find relapse, but often too late to act on it before scans show it. The randomised question, whether treating at molecular relapse helps, has not yet reported.
Reading several mutations on one fragment pushes detection below one part per million in lymphoma, where such clustered mutations are common. It has not been shown in breast cancer, where they are rarer.
A Korean residual disease test reports a limit at ten parts per million, on germline-variant mixtures rather than tumour plasma.
Subclonal variants are seen less often in residual disease than clonal ones, which is what limits attributing what is left to a subclone.
Shares IMvigor011, DYNAMIC, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment and the tag precision.
Shares Clonal haematopoiesis (CHIP), Cell-free DNA (cfDNA), Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA) and the tag precision.
Shares Cell-free DNA (cfDNA), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing and the tag precision.
Shares Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing and the tag precision.
Shares Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma, Colorectal cancer and the tag precision.
Shares Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA) and the tag precision.
Shares Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma, Colorectal cancer and the tag precision.
Shares Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma, Colorectal cancer and the tag precision.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/