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.²

ctDNA clearance and survival

100%

ctDNA-positive patients who achieved sustained clearance had 100% OS at 24 months.²

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.²

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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.³
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.

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Signatera™-positive status predicted MDT better than CEA, especially in stage II–III CRC patients

Signatera™ identified more patients eligible for curative-intent MDT during surveillance by detecting recurrence at the molecular level, when patients are still candidates for local therapy.⁴

Clinical applications for Signateraᵀᴹ in CRC

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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.

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Post-surgical MRD assessment

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

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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;

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

“Signateraᵀᴹ fired the warning shot that something was not right. Together with my HCP we had the opportunity to take the time to consider the options. She put the choice on me on what to do with a positive test result and it enabled me to choose to take a more aggressive approach.”

Keith, CRC patient

Enabling time to process and make informed plans

Giving you Latitudeᵀᴹ with MRD testing

Latitude™ is a tissue-free, blood-based, residual disease test (MRD) that delivers fast and reliable results without the need for tumor tissue. Latitude™ is built using a targeted panel, composed of differentially methylated regions specifically for colorectal cancer (CRC). Latitude™ offers strong performance, with high sensitivity and specificity for detecting residual disease in CRC patients.⁷

Learn about Latitude™

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Medically actionable information to guide treatment decisions, 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

Is Signatera™ for gastrointestinal cancer right for your patients?

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References

¹Reinert 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.

²Kotani D, et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nature Medicine. 2023;29(1).

³Nakamura Y, Watanabe J, Akazawa N, et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nature Medicine. 2024.

⁴Bratman SV, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nature Cancer. 2020;1(9):873–881. DOI: 10.1038/s43018-020-0096-5.

⁵Nowak JA, et al. Prognostic and predictive role of ctDNA in stage III colon cancer treated with celecoxib: Findings from CALGB/SWOG 80702. Presented at ASCO GI, 2025.

⁶Dasari 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.

⁷Nakamura Y, et al. Clinical validation of a tissue-free colorectal cancer test for the detection of molecular residual disease by circulating tumor DNA. Poster presented at ESMO GI, Barcelona, Spain. July 2025. Poster 93P.

⁸Zaanan A, Didelot A, Broudin C, et al. Longitudinal ctDNA analysis during treatment of resectable gastric and GEJ cancer: the PLAGAST study. Nature Communications. 2025;16:6815.

⁹Botta M, et al. Tumor-informed ctDNA predicts recurrence and survival in resected pancreatic cancer. The Oncologist. 2024. DOI: 10.1093/oncolo/oyae155.

¹⁰Abdelrahim M, et al. The feasibility of personalized and tumor-informed ctDNA assay for early recurrence detection in patients with hepatocellular carcinoma. JCO Precision Oncology, 2025.

¹¹Abdelrahim M, et al. Real-world ctDNA analysis in resected Stage I–III biliary tract cancer. Poster #420. Presented at ASCO, 2025.