Signatera™ for Colorectal Cancer
Knowing Earlier Can Make A Difference
Signatera™ is custom-built to your unique set of tumor mutations to predict colorectal cancer recurrence. Because it is highly sensitive it can detect very small traces of tumor in your body so you can know earlier if cancer is present and make more informed decisions regarding your treatment.
Pro golfer Charlie Rymer uses Signatera™ to inform his treatment.
Inform Clinical Challenges in Colorectal Cancer
Identify High Risk Patients
Evaluate which patients are likely to relapse
97% of patients
who are ctDNA+ at 4 weeks post-op will relapse without further treatment1
Detect Recurrence Early
Identify recurrence earlier
8.7 months
median lead time over radiographic recurrence1
Go Beyond Yes or No
Track treatment response via ctDNA dynamics
68.48% of ACT-treated patients
cumulatively cleared their ctDNA by week 24 and had significantly better outcomes compared to patients who remained ctDNA positive (adjusted HR 8.50 and 11 respectively, p values < 0.0001).2
Predict Adjuvant Treatment Benefit
Recent data from the largest MRD-guided trial to date indicates the Signatera™ Molecular Residual Disease Test (MRD) can help predict which patients may benefit from adjuvant treatment:
At 4 weeks post surgery:
- Post-surgical MRD status was predictive of chemotherapy benefit. Patients who were MRD-positive four weeks after surgery (18%) derived significant benefit from ACT (adjusted HR 6.59, p-value <0.001). MRD-negative patients (82%) did not see a significant benefit from ACT (p-value <0.167).3
- Post-surgical MRD status was the most significant prognostic risk factor for recurrence, in a multivariate analysis that accounted for all clinicopathological risk factors currently used for prognostication (HR 10.82, p-value <0.001).3
- Pre-surgical detection rate of 95.9% in patients with pathologic stage II-III disease and 93.1% in patients with stage II-IV disease.3
- Signatera™ dynamics are indicative of treatment response. Among the MRD-positive patients who were treated with ACT, those with ctDNA clearance had superior DFS compared to those without ctDNA clearance (adjusted HR 11, p-value <0.0001).
Powering Personalized Decisions in Early and Late Stage CRC
Discover the Colorectal Cancer Data
- Signatera™ MRD testing in colorectal cancer is validated across treatment settings.
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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
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Recurrence Monitoring
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Treatment Response Monitoring
Identify Risk in Stage II-III CRC
Signatera™ was the only significant predictor of long-term outcomes in stage II-III colorectal cancer.1,7-9
In a multivariate statistical analysis, MRD status as evaluated by Signatera™ testing had significant predictive value for long-term outcomes after adjusting for all known clinicopathological risk factors, including disease stage and lymph node status.10
Helping Patients Live With Confidence
Watch Beth’s story to learn how she and her medical oncologist used Signatera™ testing to inform important treatment decisions.
“The standard tools that we use for monitoring…are good to a certain extent, but there has to be a sufficient amount of tumor activity for them to pick up [the cancer]. We needed something more precise and that’s when I decided to utilize Signatera™”
– Dr. Anup Kasi, Beth’s oncologist at the University of Kansas
Beth’s experience with Signatera™ was determined through shared decision-making with her treating physician and family. No treatment recommendations are made or should be implied.
BESPOKE CRC Trial
Our prospective, multicenter study examines the clinical utility of the Signatera™ MRD test for monitoring recurrence and guiding treatment decisions in patients with solid tumors. Find out if your patients qualify for the BESPOKE clinical trial.
Medicare Coverage
- Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
- Muscle invasive bladder cancer (MIBC) 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
- 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
Commercial Insurance
We will work with patients so that cost is not a barrier for testing.
We offer an affordable self-pay rate for those patients who do not wish to use insurance.
Learn More About Signatera™ in Colorectal Cancer
Ready to try Signatera™ for your colorectal cancer patients?
References
1Reinert T, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124-113. https://doi.org/10.1001/jamaoncol.2019.0528
2Kotani D. et al., Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer, Nature Medicine v29 Issue 1 Jan 2023
3Kotani D. et al., Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer, Nature Medicine v29 Issue 1 Jan 2023
4Bratman SV, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020;1(9):873-881. https://doi.org/10.1038/s43018-020-0096-5
5Loupakis F, et al. Detection of molecular residual disease using personalized circulating tumor DNA assay in patients with colorectal cancer undergoing resection of metastases. JCO Precis. Oncol. 2021(5):1166-1177. https://doi.org/10.1200/PO.21.00101
6Abbosh C, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451. https://doi.org/10.1038/nature22364
7Sinicrope FA, et al. DNA mismatch repair status and colon cancer recurrence and survival in clinical trials of 5-fluorouracil-based adjuvant therapy. J Natl Cancer Inst. 2011;103(11):863–875. https://doi.org/10.1093/jnci/djr153
8Aoyama T, et al. Impact of postoperative complications on the colorectal cancer survival and recurrence: analyses of pooled individual patients' data from three large phase III randomized trials. Cancer Med. 2017;6(7):1573–1580. https://doi.org/10.1002/cam4.1126
9Yothers G, et al. Validation of the 12-gene colon cancer recurrence score in NSABP C-07 as a predictor of recurrence in patients with stage II and III colon cancer treated with fluorouracil and leucovorin (FU/LV) and FU/LV plus oxaliplatin. J Clin Oncol. 2013;31(36):4512-4519. https://doi.org/10.1200/JCO.2012.47.3116
10Corcoran RB, et al. Applications of cell-free DNA analysis to cancer treatment. N Engl J Med. 2018;379(18):1754-1765. https://doi.org/10.1056/NEJMra1706174