GALEAS™ Bladder

GALEAS™ Bladder

Bladder Cancer Diagnosis, Detection, and Screening

Ultra-Sensitive, Urine-Based, Bladder Cancer Test

GALEASBladder is a bladder cancer test developed collaboratively by researchers at the University of Birmingham in the UK and Nonacus. It utilizes next-generation sequencing (NGS) technology to analyze key somatic mutations associated with all grades and stages of bladder cancer. Based on Nonacus’s ultra-sensitive NGS technology, GALEAS Bladder accurately and sensitively detects tumor-derived gDNA present in urine.

GALEAS Bladder Video Introduction

GALEAS Bladder Video
The table of contents

Performance Data

GALEAS™ Bladder accurately detects somatic mutations present in over 96% of bladder cancer cases and has been validated using 710 urine samples from three UK clinical cohorts.

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%

GALEASTM Bladder

NMIBC

Sensitivity: 92%

Specificity: 86%

NPV: 99%

GALEASTM Bladder

MIBC

Sensitivity: 92%

Specificity: 86%

NPV: 99%

Cystoscopy (1,2)

Sensitivity: 84%

Specificity: 86%

NPV: 96%

1.Chao-Zhe Zhu, et al., J Cancer. 2019, A review on the accuracy of bladder cancer detection methods.

2.Quentin Alimi, et al., Neurourol Urodyn. 2018. Reliability of urinary cytology and cystoscopy for the screening and diagnosis of bladder cancer in patients with neurogenic bladder: A systematic review.

3.Ward et al ; Eur Urol Oncol, 2023, Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA

4.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

GALEAS™ Bladder Intervention Opportunities: Hematuria Triage

Each year, hundreds of thousands of patients with hematuria or blood in the urine are referred to medical institutions for cystoscopy to confirm the presence or absence of cancer. However, only about 10% of these referrals result in a bladder cancer diagnosis. This means that hundreds of thousands of patients undergo unnecessary, painful, and invasive procedures, leading to substantial medical costs.

GALEAS™ Bladder offers a non-invasive molecular triage for hematuria patients, enabling rapid and accurate detection of bladder cancer to streamline diagnosis. This test has been validated with urine samples from over 700 patients, demonstrating high performance across all stages and grades of bladder cancer (1, 2).

Reporting

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

Cloud-based GALEAS™ Analysis Software

The cloud-based GALEAS™ analysis software provides simple positive or negative results.

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
Protocol
The table of contents