GALEAS™ Bladder
A novel bladder cancer test providing a non-invasive, sample-to-report, molecular triage for patients with hematuriaA NEW non-invasive NGS alternative to cystoscopy for ALL stages of bladder cancer
Bladder cancer is the 5th most common cancer in the western world and 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 5 years, compared to only 36% of those with a late diagnosis1.
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 cancer2. In addition, cystoscopy can be subjective, time consuming and the result can be highly dependent on the operator 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.
1CZ Zhu, et al.(2019) A review on the accuracy of bladder cancer detection methods. Journal of Cancer,10(17):4038-4044.
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 451 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 451 somatic mutations present in over 96% of bladder cancer cases and has been validated using 664 urine samples from three UK clinical cohorts3.
| Sensitivity | Specificity | |
|---|---|---|
| pTa | 87% | 85% |
| T1 | 95% | 85% |
| T2+ | 86% | 85% |
| G1 | 78% | 85% |
| G2 | 91% | 85% |
| G3 | 91% | 85% |
| NMIBC | 90% | 85% |
| MIBC | 86% | 85% |
Figure 1: GALEAS Bladder performance across all stages of bladder cancer and compared to reported sensitivity of cytology and cystoscopy.
3DG Ward, et al. (2023) Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA, European Urology Oncology, 6(1): 67-75.
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
Offers the potential to be used 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 bar-coded 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 451 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
Lab uploads sequencing results to secure cloud-based GALEAS platform
Results analyzed, report generated and shared directly with urologist
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Nonacus is responsible for the development and ascertainment of the performance characteristics of GALEAS Bladder.
GALEAS Bladder is a Laboratory Developed Test (LDT), and not currently CE marked. Plans for future regulatory approvals are underway.