Medical Tests

Gastrointestinal Cancers

Signatera™ for Colorectal Cancer

Signatera™ is redefining the standard for MRD assessment through personalized, tumor-informed molecular testing

By custom-designing each assay to a patient’s unique cancer signature, Signatera™ identifies colorectal cancer recurrence with high sensitivity—detecting molecular relapse months ahead of traditional imaging. This window of lead time empowers clinicians to intervene earlier, optimize adjuvant therapy, and make more confident, treatment decisions.

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Inform Clinical Challenges in Colorectal Cancer

Predict overall survival

97%

of ctDNA negative patients vs. 71.8% of ctDNA positive patients had 36-month OS.¹

ctDNA clearance and survival

100%

ctDNA-positive patients who achieved sustained clearance had 100% OS at 24 months.¹

Powering personalized decisions in early and late stage CRC

Signatera™-positivity was predictive of inferior OS

Signatera™ MRD status predicted overall survival: Patients who tested Signatera™-positive after surgery had significantly worse overall survival (OS) compared to those who were Signatera™-negative.¹

All stages MRD window overall survival chart

Overall survival at the MRD window chart

Predict which CRC patients may benefit from treatment escalation

CALGB (Alliance)/SWOG 80702 publication JAMA Oncology, evaluating the predictive and prognostic value of Signatera™ in 940 stage III colon cancer treated with adjuvant FOLFOX ± celecoxib:

Signatera™-positive patients treated with both chemotherapy and celecoxib showed a 40% improvement in overall survival compared to chemotherapy alone.²
No benefit from celecoxib was observed in Signatera™-negative patients.
Celecoxib improved DFS in Signatera™-positive patients, independent of PIK3CA mutational status

Natera Cancer Care can help support this therapy recommendation

Altera™ tumor genomic profiling for patient selection + Signatera™ MRD testing.
Altera™ detects PI3K pathway mutations (PIK3CA, PTEN, PIK3R1), which guide NSAID therapy decisions.
With a single sample, you can get molecular residual disease (MRD) and tumor genomic profiling from the same tumor sample, enabling you to select the right patients for additional therapy and track their MRD status over time.

Stage III colorectal cancer patient therapy recommendation pathway

Clinical applications for Signatera™ in CRC

Neoadjuvant response monitoring

Monitor neoadjuvant response with serial Signatera™ testing. Identify low risk patients who are ctDNA-negative to potentially support a nonsurgical “watch and wait” approach.

Post-surgical MRD assessment

Identify patients at high risk of recurrence who may benefit from adjuvant chemotherapy.

Average lead time of ctDNA detection before CT scan

Recurrence monitoring

Assess for MRD more accurately than current risk assessment methods:

ctDNA-positivity in the surveillance window was predictive of inferior DFS
Compared to patients who were serially ctDNA negative, patients with ctDNA positivity at any timepoint were approximately 34 times more likely to recur (HR: 33.56, 95%CI: 26.07–43.20, P < 0.0001).¹

Clinical application: What’s the value of serial testing in the surveillance setting?

Clinical application value of serial testing in the surveillance setting

Medically actionable information to guide treatment decisions, from diagnosis through survivorship

Medically actionable information from diagnosis through survivorship

Covered by Medicare for multiple solid tumor indications

Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings

Stage II-IV breast cancer in the neoadjuvant setting, regardless of subtype Stage IIb and higher breast cancer in the adjuvant and recurrence monitoring settings

Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings

Stage I-III non-small cell lung cancer (NSCLC) in the surveillance setting

Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings

For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

References

Nakamura Y, Watanabe J, Akazawa N, et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nature Medicine. 2024.
Zhang GQ, Meyerhardt JA, Shi Q, et al. Predictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated with Celecoxib: Findings from CALGB (Alliance)/SWOG 80702. JAMA Oncology. 2025.
Dasari A, et al. Clinical utility of including circulating tumor DNA monitoring in standard of care colorectal cancer surveillance. Presented at ESMO Gastrointestinal Cancer Annual Meeting, 2025.
Reinert T, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncology. 2019;5(8):1124–113. DOI: 10.1001/jamaoncol.2019.0528.
Kotani D, et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nature Medicine. 2023;29(1).
Nakamura Y, Reiter JG, Natarajan P, et al. Validation of a methylation-based tissue-free MRD assay in colorectal cancer patients from the GALAXY study. npj Precision Oncology. 2026. https://doi.org/10.1038/s41698-026-01277-5.