Oncology GALEAS™ Bladder Cancer
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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

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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

GALEAS Bladder Cancer urine test performance compared to reported sensitivity of cytology and cystoscopy

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

  1. Urine collection device which allows patients to provide a sample in the comfort of their own home. The device is barcoded for full traceability.
  2. High-throughput genomic DNA extraction kit extracts tumor-derived DNA from urinary cell-pellets using an easily automated magnetic bead-based protocol.
  3. Comprehensive gene panel including somatic mutations found across 96% of bladder cancers.
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Cloud-based GALEAS software delivers a simple positive or negative result for the likely presence of bladder cancer

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Urologist requests a urine collection device for patient

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Patient sends barcoded urine sample to service laboratory

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Lab uploads sequencing results to secure cloud-based GALEAS platform

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Results analyzed, report generated and shared directly with urologist

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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

See our customer publications

How can GALEAS Bladder enhance the current standard of care pathway for patients with bladder cancer?

What is the sensitivity and specificity of GALEAS Bladder? And how does this compare to the current gold standard of flexible cystoscopy?

Can we work with you towards clinical evaluation of GALEAS Bladder?

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?

How do I access GALEAS Bladder testing service?

Interested in GALEAS™ Bladder?