GALEAS™ Bladder: Non-Invasive Urine-Based Bladder Cancer Test

GALEAS™ Bladder

Ultra-Sensitive, Urine-Based Bladder Cancer Test

Revolutionizing Bladder Cancer Diagnosis, Detection, and Screening

GALEAS™ Bladder is a cutting-edge, non-invasive bladder cancer test developed through a collaboration between researchers at the University of Birmingham in the UK and Nonacus. Utilizing advanced next-generation sequencing (NGS) technology, this test detects key somatic mutations associated with all grades and stages of bladder cancer. With its ultra-sensitive NGS technology, GALEAS™ Bladder accurately identifies tumor-derived gDNA in urine, offering a reliable and painless alternative to traditional diagnostic methods.

The table of contents

Why Choose GALEAS™ Bladder?

GALEAS™ Bladder Hybridization and Capture Kit
Ultra-Sensitive Detection

Identifies somatic mutations across 23 genes present in over 96% of bladder cancer cases

Non-Invasive

Simple urine-based test eliminates unnecessary invasive procedures like cystoscopy

GALEAS™ Bladder Urine Collection Device
Utilized Across Study Cohorts

Tested on 710 urine samples across three UK clinical cohorts, ensuring high accuracy and reliability

Comprehensive Reporting

Provides detailed somatic variant analysis and positive/negative results

Watch the GALEAS™ Bladder Video Introduction

GALEAS™ Bladder

Performance Data

GALEAS™ Bladder delivers exceptional performance across all stages and grades of bladder cancer:

SensitivitySpecificityNPV
pTa89%86%99%
T197%86%99%
T2+92%86%99%
G178%86%99%
G293%86%99%
G396%86%99%
NMIBC92%86%99%
MIBC92%86%99%
Figure 1: GALEAS™ Bladder performance across all stages of bladder cancer and compared to reported sensitivity of cytology and cystoscopy.

GALEASTM Bladder

NMIBC


GALEASTM Bladder

MIBC


Cystoscopy (1,2)
Current Gold Standard


Sensitivity: 92%

Specificity: 86%

NPV: 99%

Sensitivity: 92%

Specificity: 86%

NPV: 99%

Sensitivity: 84%
Specificity: 86%
NPV: 96%

GALEAS™ Bladder for Hematuria Triage

Each year, hundreds of thousands of patients with hematuria (blood in urine) undergo invasive cystoscopy procedures, yet only about 10% are diagnosed with bladder cancer. GALEAS™ Bladder offers a non-invasive molecular triage solution, reducing unnecessary procedures and associated costs while providing rapid and accurate results.

How Does GALEAS™ Bladder Support Diagnosis?

Reporting

  • A positive/negative report will be sent to the urologist
  • Details of somatic variants identified are provided

Cloud-Based GALEAS™ Analysis Software

The GALEAS™ platform provides:

  • Simple positive/negative results
  • Detailed somatic variant analysis
  • Secure, cloud-based accessibility for seamless integration into clinical workflows

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

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 et al. BJU Int. 2019, Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification

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

Ordering Information
Ordering InformationPack SizeCatalog Number
GALEAS™ urine collection device1NGS_GAL_UCD
GALEAS™ Bead Xtract: Urine gDNA extraction kit96 samplesPRE_GAL_BXG_96
GALEAS™ Bladder kit (includes 1-96 indexes and complimentary analysis of FASTQ files using GALEAS™ analysis software for up to 96 samples)96 samplesNGS_GAL_BCP_FR_96_A
GALEAS™ Bladder kit (includes 97-192 indexes and complimentary analysis of FASTQ files using GALEAS analysis software for up to 96 samples)96 samplesNGS_GAL_BCP_FR_96_B
GALEAS™ Bladder kit (includes 193-288 indexes and complimentary analysis of FASTQ files using GALEAS analysis software for up to 96 samples)96 samplesNGS_GAL_BCP_FR_96_C
GALEAS™ Bladder kit (includes 289-384 indexes and complimentary analysis of FASTQ files using GALEAS™ analysis software for up to 96 samples)96 samplesNGS_GAL_BCP_FR_96_D
GALEAS™ Bladder validation control kit48NGS_GAL_GBVC_48
Product Resources
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