Signatera
The most widely used blood test for detecting leftover cancer after surgery, personalised to each patient's tumour mutations.
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).
1.Tumour tissue and normal DNA are sequenced (whole exome)
- May 2019DesignationUS
FDA Breakthrough Device designation source
- Mar 2020ApprovalUS
Medicare coverage (MolDX) for stage II-III colorectal cancer source
- Oct 2021ApprovalUS
Medicare coverage for immunotherapy response monitoring, pan-cancer source
- Q2 2026Label changeUS
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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- TrialDYNAMIC
Shares ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer, A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled, Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials, ctDNA MRD → adjuvant therapy decision.
- Key paperDYNAMIC: a blood test safely halved chemotherapy use after surgery for stage II colon cancer
Shares ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer, ctDNA MRD → adjuvant therapy decision, GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold, Dormant cells and minimal residual disease.
- IdeaUse tumour DNA in blood to decide when to pause treatment in metastatic cancer
Shares Natera, IMvigor011, MRD / molecular residual disease testing, Liquid biopsy (ctDNA).
- TechnologyContinuous and near-continuous ctDNA monitoring
Shares Natera, Intravasation & circulating tumour cells, Drug-tolerant persister cells, MRD / molecular residual disease testing.
- TermMinimal / molecular residual disease (MRD)
Shares Intercepting late recurrence with ctDNA surveillance and oral SERDs, ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer, ctDNA-triggered escalation in early TNBC, A national residual-disease weather service: serial blood tests for every curatively treated patient, pooled.
- PersonTakayuki Yoshino
Shares GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), MRD / molecular residual disease testing, Liquid biopsy (ctDNA).
- IdeaStrip the platelet coat off travelling tumour cells in ctDNA-positive patients
Shares CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), Dormant cells and minimal residual disease, MRD / molecular residual disease testing, Liquid biopsy (ctDNA).
- IdeaA national platform trial that every ctDNA-positive patient can join
Shares IMvigor011, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), Dormant cells and minimal residual disease, MRD / molecular residual disease testing.