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Covered by Medicare for patients with muscle invasive bladder cancer

Signatera™ for Bladder Cancer

Signatera™ monitors ctDNA for bladder cancer and can help:

  • risk-stratify patients with MIBC1 2

  • predict disease recurrence early, before traditional imaging methods 2

  • predict and monitor treatment response to inform clinical decisions3


Risk-Stratify Patients

Predict who may benefit from adjuvant immunotherapy treatment1


increase in disease-free survival for ctDNA-positive patients treated with atezolizumab1


Detect Recurrence Earlier

Identify molecular recurrence ahead of radiological relapse2

96 days

median lead time to clinical recurrence2


Predict Treatment Response

98% of metastatic patients with an increase in ctDNA

After 2 Cycles

did not derive an object response to immunotherapy treatment3

Get Started

Identify MIBC patients who may benefit from adjuvant therapy after cystectomy1,4

Signatera™ ctDNA positivity after cystectomy may predict adjuvant immunotherapy treatment benefit.1,4

Extended follow-up from the Phase III, randomized IMvigor010 trial of atezolizumab vs observation in high risk adjuvant MIBC:4

  • >110% survival benefit observed in ctDNA-positive patients treated with atezolizumab (OS, HR 0.59).4
  • No treatment benefit was observed in ctDNA-negative patients treated with atezolizumab (OS, HR 1.38)4
  • 37% of patients were ctDNA-positive at C1D1 and ctDNA positivity predicted benefit from immunotherapy at 46.8-month median follow-up (OS, HR=0.59)4
  • >75% of patients with detectable ctDNA post-surgery in the observation arm recurred by 20 month follow up1
Overall survival by ctDNA

Get Actionable Insights Across the Bladder Cancer Care Journey

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  • Explore the Peer-Reviewed Data

  • The Signatera™ MRD test is clinically validated across muscle invasive bladder cancer treatment settings.
  • Neoadjuvant Response Monitoring
    Neoadjuvant Response Monitoring
    • Lack of ctDNA clearance during neoadjuvant treatment is shown to be a better predictor of recurrence than pathologic response.2
  • Post-Surgical MRD Assessment
  • Recurrence Monitoring
  • Immunotherapy Response Monitoring

Learn About Advances in ctDNA-Guided Treatment for Urothelial Carcinoma

In this webinar, Dr. Thomas Powles shares the findings of the IMvigor010 data analysis and potential applications for ctDNA testing in bladder cancer. Dr. Powles will discuss the utility of Signatera™ MRD testing for:

  • Early detection of molecular relapse, potentially allowing clinicians to treat at lower levels of disease burden
  • Predicting treatment response as early as cycle 3 of immunotherapy
  • Future decision-making in the neoadjuvant setting

Discover the Published Data in Bladder Cancer

ABACUS: Neoadjuvant Atezolizumab in Cisplatin-ineligible Patients with Muscle-invasive Urothelial Cancer of the Bladder

Journal: European Urology
Year: 2022


View Publication

ctDNA guiding adjuvant immunotherapy in urothelial carcinoma

Journal: Nature
Year: 2021


View Publication

The effect of surgical trauma on circulating free DNA levels in cancer patients - implications for studies of circulating tumor DNA

Journal: Molecular Oncology
Year: 2020


View Publication

Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients with Urothelial Bladder Carcinoma

Journal: Journal of Clinical Oncology
Year: 2019


View Publication

European Association of Urology (EAU) 2022

Gschwend JE, Assaf ZJ, Mariathasan S, et al. Overall survival by circulating tumor DNA status in patients with post-operative muscle-invasive urothelial carcinoma treated with atezolizumab: Update from IMvigor010. EAU, Amsterdam, Netherlands, July 1-4, 2022.

View Poster

ASCO GU 2022

Powles T, Young A, Nimeiri H, et al. Molecular residual disease (MRD) detection with a tissue comprehensive genomic profiling (CGP)-informed personalized monitoring assay: An exploratory analysis of the IMvigor010 observation arm. ASCO Genitourinary Cancer Symposium, San Francisco, CA. Feb 17-19, 2022.

View Poster

ESMO 2018

Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of Plasma cfDNA from Patients with Locally Advanced Bladder Cancer for Surveillance and Therapeutic Efficacy Monitoring. Poster presented at: European Society for Medical Oncology; October 19-23, 2018; Munich, Germany.

View Poster

AACR 2018

Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of Plasma cfDNA from Patients with Locally Advanced Bladder Cancer for Surveillance and Therapeutic Efficacy Monitoring. Poster presented at: American Association for Cancer Research; April 14-18, 2018; Chicago, IL.

View Poster

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.

Learn More

Medicare Coverage

Signatera™ is covered by Medicare for immunotherapy treatment response monitoring across all solid tumor types and stages of cancer.

IO Monitoring Brochure

Learn how Signatera™ can assess immunotherapy response as early as 6 weeks into treatment for patients with solid tumors.1

IMvigor010 Pub Summary

Learn more about the IMvigor010 trial and review Signatera™’s bladder cancer data in detail.

Is Signatera™ right for your bladder cancer patients?

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1Powles T, Assaf ZJ, Davarpanah N, et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature. 2021;595(7867):432-437. doi:10.1038/s41586-021-03642-9.

2Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019;37(18):1547-1557. doi:10.1200/JCO.18.02052.

3Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nature Cancer. 2020;1:873-881. doi:10.1038/s43018-020-0096-5.

4Powles T, et al. European Urology. 2023;

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