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Signatera is Natera's tumour-informed blood test that tracks 16 mutations from each patient's own tumour to detect residual or returning cancer after surgery. Medicare covers it in colorectal, breast, bladder, lung and ovarian cancer and for immunotherapy monitoring, and in 2026 it selected the bladder cancer patients for the first approval based on circulating tumour DNA.
Signatera is Natera's tumour-informed MRD test and tracks 16 patient-specific variants. Medicare-covered in colorectal, breast, bladder, lung, ovarian, and immunotherapy monitoring. Used in interventional trials (CIRCULATE-US, ZEST in TNBC with niraparib, negative for feasibility reasons; IMvigor011 used Signatera to select ctDNA+ bladder patients for atezolizumab, leading to the first ctDNA-based approval in 2026).
WES of tumour → bespoke 16-plex PCR/NGS assay on plasma at very high depth.
1.Tumour tissue and normal DNA are sequenced (whole exome)
FDA Breakthrough Device designation source
Medicare coverage (MolDX) for stage II-III colorectal cancer source
Medicare coverage for immunotherapy response monitoring, pan-cancer source
Used to select ctDNA-positive patients in the first ctDNA-guided drug approval (IMvigor011, atezolizumab) source
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare covers colorectal (stage II-III and IV), muscle-invasive bladder, breast (neoadjuvant/adjuvant), ovarian, NSCLC and pan-cancer immunotherapy monitoring under MolDX; commercial coverage growing | ~$3,500 per test (Medicare rate, approximate) | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Together with the JCO Precision Oncology cohort this makes residual disease testing in biliary cancer prognostic to the same degree as in colon cancer. Nobody has yet shown that acting on it helps; that is the trial gap the ideas on this page name.
Very wide confidence intervals from a small cohort, but the direction matches the larger 2026 analysis. Gallbladder cancer recurs early and distantly after re-resection, which is exactly the setting where a residual disease test could pick who gets more than capecitabine.
After bladder removal, a blood test can now tell who needs immunotherapy and who can safely be spared it. This is the model for MRD-guided adjuvant therapy across cancers: treat the blood-positive, watch the blood-negative.
The blood test stratifies risk far better than stage or pathology. It supports treating ctDNA-positive patients and suggests ctDNA-negative patients gain little from chemotherapy, but because treatment was not randomised the de-escalation claim needs the randomised trials that are now under way.
For stage II colon cancer, where most patients are cured by surgery alone, a blood test can identify the minority who benefit from chemotherapy and spare everyone else its side effects. It does not yet prove that treating ctDNA-positive patients improves survival compared with not treating them.
It reframes the blood test from a yes-or-no residual disease result into a measure of how well chemotherapy is working and how fast a relapse is coming, which is what an escalation trial would need.
ctDNA clearance may refine pCR as a surrogate: a patient with residual disease but no ctDNA may not need escalation, the hypothesis behind ctDNA-guided post-neoadjuvant trials.
It showed that serial rather than single testing is what makes residual disease detection work, and it set the sampling schedule most later studies have used.
Query for this drug: (TITLE:"Signatera" OR ABSTRACT:"Signatera") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Signatera, not a curated reading list.
Shares A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled, Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer, ALTAIR, Jeanne Tie.
Shares Oncodetect, Intercepting late recurrence with ctDNA surveillance and oral SERDs, Circulating tumor DNA as a clinical test in resected pancreatic cancer, BESPOKE CRC.
Shares Oncodetect, Circulating tumor DNA as a clinical test in resected pancreatic cancer, BESPOKE CRC, Circulating tumor DNA as a potential marker of adjuvant chemotherapy benefit following surgery for localized pancreatic cancer.
Shares Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer, Circulating tumor DNA in stage III colorectal cancer, beyond minimal residual disease detection, toward assessment of adjuvant therapy efficacy and clinical behavior of recurrences, Natera, GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold.
Shares ALTAIR, DYNAMIC-III, CIRCULATE-US, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR).
Shares Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer, Circulating tumor DNA in stage III colorectal cancer, beyond minimal residual disease detection, toward assessment of adjuvant therapy efficacy and clinical behavior of recurrences, Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer, Tumour-informed versus tumour-naive ctDNA assays.
Shares ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative, ctDNA MRD positivity (molecular residual disease after curative treatment), ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Dormant cells and minimal residual disease.
Shares ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative, ctDNA MRD positivity (molecular residual disease after curative treatment), ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Dormant cells and minimal residual disease.