Signatera™ for GU Cancers
Signatera™ monitors ctDNA to provide molecular insights across genitourinary (GU) cancers, helping clinicians:
- Identify patients at higher risk of recurrence across GU cancers
- Detect recurrence earlier than traditional imaging
- Monitor treatment response to inform personalized care decisions
Predict Adjuvant Treatment Benefit
In MIBC, ctDNA-positive patients treated with atezolizumab had a
42%
increase in disease-free survival1
Detect Recurrence Earlier
In MIBC, Signatera™ predicted recurrence up to
245 days
before clinical recurrence (median=96 days)2
Predict Treatment Response
In MIBC and other cancers, increases in ctDNA have been associated with lack of response to immunotherapy.
After 2 Cycles
did not derive an object response to immunotherapy treatment in a pan-tumor trial3
Get Started
Explore Previously Presented Signatera™ Results in MIBC
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
Get Actionable Insights Across the Genitourinary (GU) Cancer Care Journey
Signatera™ is Clinically Validated
- The Signatera™ MRD test is clinically validated across muscle invasive bladder cancer treatment settings.
Explore the peer-reviewed data.
-
IMvigor011 Study
Patients who remain serially SignateraTM negative post-cystectomy may be spared adjuvant therapy, underscoring the value of longitudinal monitoring5- SignateraTM ctDNA-negative patients who were untreated had:
- OS rates of 100% at 12 months and 98% at 18 months5
- DFS rates of 92% at 12 months and 88% at 18 months5
-
IMvigor010 Study
-
INSPIRE Study
-
Aarhus University Study
Explore real-world cases
-
Post-Surgical MRD Assessment
Discover the Published Data in Bladder Cancer
- PUBLICATIONS
- POSTERS
ABACUS: Neoadjuvant Atezolizumab in Cisplatin-ineligible Patients with Muscle-invasive Urothelial Cancer of the Bladder
ctDNA guiding adjuvant immunotherapy in urothelial carcinoma
The effect of surgical trauma on circulating free DNA levels in cancer patients - implications for studies of circulating tumor DNA
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
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.
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.
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.
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.
Testicular Cancer
Signatera™’s clinical validation in testicular cancer ctDNA studies
A recent series of prospective studies evaluated whether Signatera™ could improve recurrence detection and assess treatment response in patients with testicular cancer.
- In patients with stage I testicular cancer, tumor-informed ctDNA demonstrated a specificity of 96.3% and NPV of 86.7% compared with imaging for detecting recurrence; undetectable serial ctDNA results may help reduce unnecessary imaging surveillance.6
- In the RPLND setting, detectable ctDNA in the post-operative MRD window was strongly associated with progression: all patients with detectable ctDNA relapsed, whereas none with undetectable ctDNA experienced recurrence.7
Detect recurrence early and monitor treatment response with Signatera™
Signatera™ detected testicular cancer recurrence with 96% specificity and 87% NPV compared to imaging in stage I disease, and predicted progression with 100% accuracy in the post-RPLND MRD setting
- In patients with stage I testicular cancer, ctDNA demonstrated 96.3% specificity and 86.7% NPV, suggesting serial negative results could allow safe reduction of imaging burden.9
- Among patients who underwent RPLND, all with detectable ctDNA in the post-operative MRD window progressed, while none with undetectable ctDNA recurred.9
- Patients with persistently negative ctDNA after treatment remained disease-free during surveillance, supporting its role in guiding escalation or de-escalation of therapy.
Medicare Coverage
- 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 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
Commercial Insurance
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.
Bladder Cancer Brochure
Learn more about Signatera™ for bladder cancer
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?
References
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; https://doi.org/10.1016/j.eururo.2023.06.007.
5Powles T, et al. Presented at EAU annual conference, 2024.
6American Cancer Society. Key statistics for testicular cancer. 2025. Available at: https://www.cancer.org/cancer/types/testicular-cancer/about/key-statistics.html
7Reuben Ben-David, et al. Utility of tumor-informed circulating tumor DNA (ctDNA) in patients undergoing retroperitoneal lymph node dissection for testicular cancer. Icahn School of Medicine at Mount Sinai. Poster presented in 2023.
8Parth Thakker, et al. Circulating tumor DNA as a prognostic biomarker to predict retroperitoneal histology in patients undergoing retroperitoneal lymph node dissection. Indiana University. Poster presented at ASCO GU, 2025.
9Reuben Ben-David, et al. Comparative performance of tumor-informed circulating tumor DNA and imaging studies in monitoring patients with Stage I testicular cancer. Icahn School of Medicine at Mount Sinai. Poster presented at ASCO GU, 2024.