Signatera™ MRD Test
Covered by Medicare for muscle-invasive bladder cancer (MIBC)
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
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
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
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
Get Actionable Insights Across the Bladder Cancer Care Journey
Explore the Peer-Reviewed Data
- The Signatera™ MRD test is clinically validated across muscle invasive bladder cancer treatment settings.
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
Immunotherapy Response Monitoring
Discover the Published Data in Bladder Cancer
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?
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.