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Covered by Medicare for patients with stage II-IV and oligometastatic colorectal cancer

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

Get Started

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

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  • Discover the Colorectal Cancer Data

  • Signatera™ MRD testing in colorectal cancer is validated across treatment settings.
  • Neoadjuvant Response Monitoring
    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
  • Recurrence Monitoring
  • 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.


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

Signatera™ is covered by Medicare for monitoring disease progression, disease recurrence, or relapse for patients with:
  • 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 welcome all insurance plans.

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.

Ready to try Signatera™ for your colorectal cancer patients?

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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.

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.

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.

6Abbosh C, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.

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.

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.

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.

10Corcoran RB, et al. Applications of cell-free DNA analysis to cancer treatment. N Engl J Med. 2018;379(18):1754-1765.

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