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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 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.

Inform Clinical Challenges in Colorectal Cancer

Test

Identify High Risk Patients

80%

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

Know

Predict Overall Survival

36-month OS

96%

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

Decide

ctDNA clearance and survival

100%

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

Get Started

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

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
  • 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

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Stage II-IV and oligometastatic colorectal cancer (CRC) in the adjuvant and recurrence monitoring settings
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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
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Muscle invasive bladder cancer (MIBC) in the adjuvant and recurrence monitoring settings
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Stage II-IV ovarian, fallopian tube, or primary peritoneal cancer in the adjuvant and recurrence monitoring settings
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For monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

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

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