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Transforming the management of cancer with personalized testing

Signatera™ is a highly sensitive and personalized molecular residual disease assay (MRD) using circulating tumor DNA (ctDNA), custom designed for each patient to help identify relapse earlier than standard of care tools.

Signatera™ is covered by Medicare for monitoring disease progression, disease recurrence, or relapse for patients with:

  • Colorectal cancer (CRC), muscle invasive bladder cancer (MIBC), stage IIb and higher breast cancer
  • Monitoring of response to immune-checkpoint inhibitor (ICI) therapy for patients with any solid tumor

Signatera™ has significant predictive value for long-term patient outcomes

The only significant risk factor in stage II-III colorectal cancer5‑8

In multivariate statistical analysis, MRD status as measured by Signatera™ was the only significant predictor of long-term cancer patient outcomes, after adjusting for all known clinicopathological risk factors including disease stage and lymph node status.1


Will my patient benefit from adjuvant chemotherapy?

Determining which colorectal cancer patients benefit from adjuvant chemotherapy isn’t always clear using current standard of care tools. The GALAXY study set out to better understand if a personalized ctDNA assay can aid risk stratification, better than TNM staging for recurrence.

Check out recent findings published in Nature Medicine

Study Overview: CIRCULATE-Japan (prospective large-scale registry)

  • 1,039 patients with Stage II-IV colorectal cancer (CRC), enrolled into the observational GALAXY arm of CIRCULATE-Japan, with median clinical follow up of 16.7 months; a subset of patients received adjuvant treatment (ACT) at physicians’ discretion
  • Results were analyzed to determine 18-month disease-free survival (DFS), by molecular residual disease (MRD) status and by treatment status.1

Signatera™ Residual Disease Test (MRD) positivity may be prognostic of survival outcomes post-surgery:

  • MRD positivity in patients 4 weeks after surgery were associated with a significantly higher risk of recurrence and inferior disease-free survival (DFS) at 18 months of follow-up (HR 10.0, p value <0.0001), regardless of stage.
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When to use Signatera™ MRD test?

Adjuvant setting

  • Use after to surgery to evaluate the need for adjuvant chemotherapy
  • To personalize and help inform when to escalate or right-size treatment

Surveillance setting

  • Detect MRD with greater sensitivity than current standard of care tools
  • Use Signatera™ alongside CEA to detect relapse earlier and reduce false positive CEA results
Signatera high sensitivity and specificity
“Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity. Signatera™ enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging.”
Lajos Pusztai, MD, DPhil

Lajos Pusztai, MD, DPhil

Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine

Signatera™ can help guide care for your cancer patients

Risk level Actionable results: Stage II-III Colorectal Test Interpretation
ctDNA High Risk Consider directed imaging (PET/MRI) to locate the disease while potentially resectable >97% of patients will relapse
ctDNA Reduced Risk Continue monitoring with reassurance 12-14% patients may relapse. Patients who remain negative 2 years post treatment have risk reduced to 3%
Bespoke CRC

Do your patients qualify for the BESPOKE CRC trial?

Our prospective, multicenter study examines the clinical utility of the Signatera™ ctDNA test for monitoring recurrence and guiding treatment decisions in patients with solid tumors. Find out if your patients qualify for the BESPOKE clinical trial.


Is Signatera™ right for you?

We’re here to help you find out


1Corcoran RB, Chabner BA. N Engl J Med. 2018;379(18):1754-1765.

2Kramer J, Price ER, Jochelson MS, et al. Eur Radiol. 2017;27(11):4812-4818.

3Borcoman E, Nandikolla A, Long G, Goel S, Le Tourneau C. Am Soc Clin Oncol Educ Book. 2018;38:169-178.

4Perkins GL, Slater ED, Sanders GK, Prichard JG. Am Fam Physician. 2003;68(6):1075-1082.

5Reinert T, Henriksen TV, Christensen E, et al. JAMA Oncol. 2019. doi:10.1001/jamaoncol.2019.0528.

6Sinicrope FA, Foster NR, Thibodeau SN, et al. J Natl Cancer Inst. 2011;103(11):863–875.

7Aoyama, Oba K, Honda M, et al. Cancer Med. 2017;6(7):1573–1580.

8Yothers G, O’Connell MJ, Lopatin M, et al. J Clin Oncol. 2013;31(36):4512-4519.

9Kotaka et al. ASCO GI 2022.

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