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Nonacus

GALEAS™ Bladder

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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.

ÁRAJÁNLATOT, INFORMÁCIÓT KÉREK!

 

 

 

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 in 23 genes associated with bladder cancer.

 

Provides simple and quick reporting provided by the cloud-based GALEAS software, saving precious time when evaluating patient needs.

 

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 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.

 

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

 

 

 

 

Műszaki specifikációk

 

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 cystoscopyhttps://nonacus.com/wp-content/uploads/2023/10/GALEAS-Bladder-sensitivity-compared-to-cystoscopy-and-cytology-300x156.png 300w, https://nonacus.com/wp-content/uploads/2023/10/GALEAS-Bladder-sensitivity-compared-to-cystoscopy-and-cytology-1024x532.png 1024w, https://nonacus.com/wp-content/uploads/2023/10/GALEAS-Bladder-sensitivity-compared-to-cystoscopy-and-cytology-768x399.png 768w" sizes="(max-width: 1150px) 100vw, 1150px" title="GALEAS-Bladder-sensitivity-compared-to-cystoscopy-and-cytology" style="box-sizing: border-box; display: inline; width: 637px;">
 

Figure 1: GALEAS Bladder performance compared to reported sensitivity of cytology and cystoscopy.

GALEAS Bladder performance across all stages of bladder cancer

 
pTa 86% 86%
T1 95% 86%
T2+ 89% 86%
G1 76% 86%
G2 92% 86%
G3 92% 86%
NMIBC 89% 86%
MIBC 89% 86%

 

Tartozékok, kiszerelések

 

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 somatic mutations found across 96% of bladder cancers.
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