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Signatera™

Tumor-informed testing in bladder cancer

Signatera™ can help:

  • risk-stratify patients with muscle-invasive bladder cancer (MIBC)1 2

  • predict disease recurrence early, before traditional imaging methods 2

  • predict and monitor treatment response to inform clinical decisions3

Signatera is now covered by Medicare in muscle invasive bladder cancer
Overall survival by ctDNA

Assess risk and predict treatment benefit

Signatera testing after cystectomy can help risk-stratify patients and identify who may benefit from adjuvant treatment.1

Retrospective analysis of IMvigor010 (Phase III, randomized clinical trial of atezolizumab vs observation in high risk adjuvant MIBC) demonstrated Signatera may be:

  • Predictive of benefit of treatment with atezolizumab (overall survival hazard ratio OS HR=0.59)1
  • Prognostic of overall patient outcomes in observation arm (OS HR=8.00 with 95% CI: 4.92, 12.99 and P<0.001)1

Detect recurrence early

Signatera testing after definitive treatment can identify molecular recurrence ahead of radiological relapse.2

  • Out of 64 patients, ctDNA was detected in 17 patients after cystectomy, and 13 of these were diagnosed with a recurrence2
  • For patients with metastatic relapse and detectable ctDNA, the lead time over conventional imaging was up to 245 days with a median of 96 days2
Detect Recurrence Early Graph

Published Data

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

Journal: European Urology
Year: 2022

 

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ctDNA guiding adjuvant immunotherapy in urothelial carcinoma

Journal: Nature
Year: 2021

 

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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

 

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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

 

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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.

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AACR 2019

Christensen E (Aarhus, Denmark). 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. American Association of Cancer Research (AACR); March 29-April 3, 2019; Atlanta, GA.

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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.

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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.

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Advances in ctDNA-guided treatment for urothelial carcinoma

Personalized molecular residual disease (MRD) testing

figure

Personalized, tumor-informed assay

One-time, primary tissue sample and matched normal tissue is required for whole exome sequencing and personalized test design.

Test Tube

Ultrasensitive ctDNA detection

Signatera is designed to detect ctDNA of somatic and truncal variants to optimize sensitivity. Tumor-informed method enables filtering of CHIP mutations to decrease false positive rates.

Graph

Optimized for longitudinal monitoring

Once the patient’s personalized test has been designed, only a blood sample is needed each subsequent time Signatera is ordered for the adjuvant program or surveillance program.

How to order Signatera for your patients?

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Lab Equipment

Contact Natera for Support

Call Natera at 650-489-9050 or fill out our contact form.




References

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

2Christensen E, 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. https://doi.org/10.1200/JCO.18.02052

3Bratman 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