DPYD Genotyping is available as an optional add-on to initial Signatera™ orders
Learn MoreDPYD Genotyping is available as an optional add-on to initial Signatera™ orders
Learn MoreInform 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
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.
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.3
Clinical applications for Signateraᵀᴹ 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.
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?
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.6
DPYD genotyping is now available as an optional add-on to initial Signatera™ orders
Runs from the existing EDTA tube on the first Signatera™ order, no additional blood draw.
of patients carry a DPYD risk variant7
grade ≥3 toxicity in DPYD*2A carriers8
treatment-related death, carriers vs non-carriers
Severe toxicities: neutropenia, severe diarrhea, mucositis, hand-foot syndrome, neurotoxicity8,9
less severe toxicity in carriers identified before treatment, on a modified dose8
guideline-recommended variants included10
Medically actionable information to guide treatment decisions, from diagnosis through survivorship
Covered by Medicare for multiple solid tumor indications
Is Signatera™ for gastrointestinal cancer right for your patients?
1Nakamura Y, Watanabe J, Akazawa N, et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nature Medicine. 2024.
2Zhang 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.
3Dasari 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.
4Reinert 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.
5Kotani D, et al. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nature Medicine. 2023;29(1).
6Nakamura 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.
7Amstutz U, Henricks LM, Offer SM, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for dihydropyrimidine dehydrogenase genotype and fluoropyrimidine dosing: 2017 update. Clin Pharmacol Ther. 2018;103(2):210-216. doi:10.1002/cpt.911.
8Henricks LM, Lunenburg CATC, de Man FM, et al. DPYD genotype-guided dose individualisation of fluoropyrimidine therapy in patients with cancer: a prospective safety analysis. Lancet Oncol. 2018;19(11):1459-1467. doi:10.1016/S1470-2045(18)30686-7.
9Sharma BB, Rai K, Blunt H, Zhao W, Tosteson TD, Brooks GA. Pathogenic DPYD variants and treatment-related mortality in patients receiving fluoropyrimidine chemotherapy: a systematic review and meta-analysis. Oncologist. 2021;26(12):1008-1016. doi:10.1002/onco.13967.
10Pratt VM, Cavallari LH, Fulmer ML, et al. DPYD genotyping recommendations: a joint consensus recommendation of the Association for Molecular Pathology, American College of Medical Genetics and Genomics, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group, European Society for Pharmacogenomics and Personalized Therapy, Pharmacogenomics Knowledgebase, and Pharmacogene Variation Consortium. J Mol Diagn. 2024;26(10):851-863. doi:10.1016/j.jmoldx.2024.05.015.