A non-invasive comprehensive biomarker test for bladder cancer
GALEASTM Bladder
A novel bladder cancer test providing a non-invasive, sample-to-report, molecular triage for patients with hematuria.
A non-invasive NGS alternative to cystoscopy for ALL stages of bladder cancer
Bladder cancer is the 5th most common cancer in the western world It accounts for ~600,000 new cancers diagnosed and causes ~250,000 deaths worldwide each year. When diagnosed early, over 90% of patients with bladder cancer will survive five years, compared to only 36% of those with a late diagnosis.1
Blood in the urine (hematuria) is one of the most common signs of bladder cancer. Patients with hematuria are investigated by cystoscopy, an uncomfortable, invasive and expensive procedure to visually inspect the bladder. However, 90% of patients investigated do not have bladder cancer.2 In addition, cystoscopy can be subjective, time consuming and the result can be highly dependent on the operator's expertise.
There is therefore a clear need for a non-invasive, highly accurate test to improve bladder cancer patient management by reducing the number of cystoscopies necessary for the triage of patients with hematuria and for the monitoring of patients with bladder cancer.
“A recent breakthrough in diagnostics could make it easier to detect patients early”.
The Telegraph
A comprehensive biomarker test for detecting bladder cancer from a simple urine sample. It offers a complete sample to report solution for doctors, clinics, service laboratories and patients.
GALEAS Bladder
GALEAS Bladder is a simple, sample-to-report urine test to detect the presence of bladder cancer. Developed in partnership with researchers at the University of Birmingham, UK, the test leverages ultra-sensitive targeted Next Generation Sequencing (NGS) to interrogate the key somatic mutations found across all grades and stages of bladder cancer.
Delivering sensitivity of >90%, GALEAS Bladder allows urologists to make an informed, safe decision about determining which patients may need further investigation and which don’t.
- Is a highly sensitive diagnostic test, equivalent to cystoscopy for all grades and stages of bladder cancer, including non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC)
- Has the potential to be used across the whole bladder cancer care pathway including patient monitoring, relapse and minimal residual disease (MRD) surveillance as well as hematuria triage
- Uses a simple urine sample to investigate the presence of tumor-derived DNA
- Leverages ultra-sensitive targeted NGS chemistry developed by Nonacus, to detect somatic mutations associated with bladder cancer
- Provides simple and quick reporting provided by the cloud-based GALEAS software, saving precious time when evaluating patient needs
GALEAS Bladder enables the highly sensitive and accurate detection of tumor-derived DNA across all stages and grades of bladder cancer
GALEAS Bladder accurately detects somatic mutations present in over 96% of bladder cancer cases and has been validated using 770 urine samples from three UK clinical cohorts.3
Figure 1: GALEAS Bladder performance compared to reported sensitivity of cytology and cystoscopy.
| pTa | 86% | 86% |
| T1 | 95% | 86% |
| T2+ | 89% | 86% |
| G1 | 76% | 86% |
| G2 | 92% | 86% |
| G3 | 92% | 86% |
| NMIBC | 89% | 86% |
| MIBC | 89% | 86% |
Why choose GALEAS Bladder?
Capable of detecting ALL stages of bladder cancer
Delivers sensitivity and specificity equivalent to cystoscopy for all bladder cancer grades including both NMIBC and MIBC.
End-to-end solution for triage of bladder cancer
From simple, at home sample collection through to a positive or negative actionable report, the process is streamlined for both patient and clinician.
Offers the potential for use across the whole bladder cancer care pathway
By covering a wide range of markers, GALEAS Bladder can be used for patient monitoring, relapse, MRD surveillance and companion diagnostics as well as hematuria triage.
The components of GALEAS Bladder
- Urine collection device which allows patients to provide a sample in the comfort of their own home. The device is barcoded for full traceability.
- High-throughput genomic DNA extraction kit extracts tumor-derived DNA from urinary cell-pellets using an easily automated magnetic bead-based protocol.
- Comprehensive gene panel including somatic mutations found across 96% of bladder cancers.
Cloud-based GALEAS software delivers a simple positive or negative result for the likely presence of bladder cancer
Urologist requests a urine collection device for patient
Patient sends barcoded urine sample to service laboratory
Lab uploads sequencing results to secure cloud-based GALEAS platform
Results analyzed, report generated and shared directly with urologist
Urologist shares results with patient and discusses next steps
Interested in adding GALEAS Bladder as a test in your clinical laboratory?
Interested in accessing GALEAS Bladder for your patients?
For Research Use Only. Not for use in diagnostic procedures. Plans for future regulatory approvals are underway. Nonacus is responsible for the development and ascertainment of the performance characteristics of GALEAS Bladder.
References
1. Zhu, C. Z., Ting, H. N., Ng, K. H., & Ong, T. A. (2019). A review on the accuracy of bladder cancer detection methods. Journal of cancer, 10(17), 4038. Full article
2. Alimi, Q., Hascoet, J., Manunta, A., Kammerer‐Jacquet, S. F., Verhoest, G., Brochard, C., ... & Peyronnet, B. (2018). Reliability of urinary cytology and cystoscopy for the screening and diagnosis of bladder cancer in patients with neurogenic bladder: a systematic review. Neurourology and Urodynamics, 37(3), 916-925. Full article
3. Ward DG, Gordon NS, Boucher RH, et al. Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification. BJU Int. 2019;124(3):532-544. doi:10.1111/BJU.14808. Full article
See our customer publications
How can GALEAS Bladder enhance the current standard of care pathway for patients with bladder cancer?
The current standard of care pathway for patients with hematuria (blood in urine) is to undergo a flexible cystoscopy procedure. This procedure requires a hospital visit and can be invasive and uncomfortable for the patient. The procedure costs the healthcare provider both time and money and in the UK, flexible cystoscopy costs the NHS £88 million per year. In addition, the sensitivity and specificity of cystoscopy is operator dependent and 88% of procedures turn out to be unnecessary.
Whereas, GALEAS Bladder requires the patient to provide a simple urine sample, which can be collected in the comfort of their own home. This new test can detect all stages and grades of bladder cancer and by covering such a wide range of markers, GALEAS bladder offers the potential to be used across the whole bladder cancer care pathway; from hematuria triage, patient monitoring, detecting relapse, minimal residual disease (MRD) surveillance as well as companion diagnostics. This would reduce the burden in cystoscopy clinics and provide greater comfort to patients.
What is the sensitivity and specificity of GALEAS Bladder? And how does this compare to the current gold standard of flexible cystoscopy?
GALEAS Bladder has equivalent sensitivity and specificity to cystoscopy (Table 1 and Figure 1) across all grades and stages of bladder cancer, it therefore has the capability of reducing cystoscopies by around 90%.
Can we work with you towards clinical evaluation of GALEAS Bladder?
Yes. We are looking for partners to provide samples to validate our panel for use in NMIBC and MIBC surveillance as well as comparison diagnostics and stratification.
I would like to work with you on setting this up in my clinical laboratory and for clinical validation, how do I go about doing this?
We are always looking for partners to provide samples to further validate our panel for use in NMIBC and MIBC surveillance as well as companion diagnostics and stratification. If you are interested in collaborating with us please get in touch via the get in touch form provides below and one of our team will be in touch with you.
How do I access GALEAS Bladder testing service?
GALEAS Bladder service testing is currently provided by Informed Genomics ltd.
