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 setting the standard for MRD testing. Each assay is custom designed to predict colorectal cancer recurrence earlier than standard of care tools. Because it is highly sensitive it can detect very small traces of tumor left in the patient’s body so you can know earlier if cancer is present and make more informed treatment decisions.

Pro golfer Charlie Rymer uses Signatera™ to inform his treatment.

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Inform Clinical Challenges in Colorectal Cancer

Identify High Risk Patients

80%

Of CRC patients are cured by surgery alone — knowing which patients would benefit from ACT is often unclear¹

Predict Overall Survival

36-month OS

96%

in ctDNA negative patients vs. 71.8% in ctDNA positive patients²

ctDNA clearance and survival

100%

MRD-positive patients who achieved sustained clearance had 100% OS at 24 months²

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

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Predict Adjuvant Treatment Benefit

The latest GALAXY findings² from the CIRCULATE-Japan trial analyzes >2,240 patients with stage II– IV colorectal cancer and includes 36M-DFS and 24M- OS data demonstrating the importance of post-surgical ctDNA analysis and its association with long term survival:

Reinforces Signatera™’s ability to predict adjuvant chemotherapy (ACT) benefit in resectable CRC
Signatera™’s ability to identify sustained ctDNA clearance is an indicator of a superior survival benefit derived from ACT, compared to patients who did not achieve ctDNA clearance
Patients who clear their ctDNA and remain Signatera™-negative have superior DFS and OS, compared to those with transient clearance converting back positive and those with no ctDNA clearance

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CRC_Adjuvant_Treatment_Benefit_20241206_537x416

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.
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
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;
ctDNA clearance

Enabling time to process and make informed plans

“Signatera 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

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

Learn More About Signatera™ in Colorectal Cancer

CIRCULATE-Japan Trial

Learn more about the clinical utility of the Signatera™ test in the largest prospective MRD study to date

Read the Summary

Signatera™ in Oligometastatic CRC

Learn about data published in the Journal of Clinical Oncology showing that MRD status was the only significant post-surgical prognostic factor.

Read the Study Overview

CRC Brochure

Learn more about how the Signatera™ MRD test in colorectal cancer informs important care decisions.

Get the Brochure

Testing Options

Learn about the testing process, including timelines and remote blood draw services.

Get the Manual

Access Guide

Find information about billing, including Medicare coverage for stage II/III CRC, pan-cancer immunotherapy monitoring, and muscle invasive bladder cancer.

Read the Guide

Introducing Signatera™ Video

Watch an overview of the Signatera™ test’s innovative technology and how it can support more informed treatment decisions.

Watch the Video

Published Data in CRC

See the published data.

View Publications

Ready to try Signatera™ for your colorectal cancer 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 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