GALEAS Bladder

A non-invasive NGS-based molecular test for identifying bladder cancer from a urine sample

A non-invasive, sample to report, molecular triage test for bladder cancer

GALEAS Bladder is a simple, sample-to-report urine test to detect the presence of bladder cancer.

It leverages ultra-sensitive, targeted next generation sequencing (NGS) chemistry to interrogate somatic mutations in 23 genes associated with bladder cancer in tumor-derived genomic DNA extracted from a urine sample. It offers a viable non-invasive molecular biomarker alternative to flexible cystoscopy.

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One test for ALL stages of bladder cancer
Delivers sensitivity and specificity equivalent to cystoscopy for both Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC).
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Sample to answer solution
From home sample collection through to bioinformatics and reporting, the process is optimized and streamlined to maximize efficiencies.
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Automated and scalable workflow
GALEAS Bladder can be run in any NGS capable laboratory and automated and scaled according to throughput.

GALEAS Bladder workflow

 

Service laboratory dispatches bar coded GALEAS Urine Collection Device to patient

Returned urine sample is centrifuged and gDNA extracted from cell pellet using Bead Xtract Urine gDNA Extraction Kit

NGS libraries are prepared with the GALEAS Bladder Kit and sequenced. 5M reads (2 x 150bp PE reads)
FASTQ files are uploaded to secure cloud-based GALEAS Analysis platform
Results are analyzed, report generated and shared directly with requesting physician
GALEAS Urine Collection Device
GALEAS Urine Collection Device

Shipped ready for dispatch to patients, the simple, intuitive cardboard collection device allows patients to provide a urine sample in the comfort of their own home.

The sample is returned to the lab in a 50ml Falcon tube containing our proprietary preserver validated with our DNA extraction kit and panels to ensure optimal performance.

The tube is barcoded to provide full traceability.

Bead Xtract Urine gDNA Extraction Kit
GALEAS Bladder Urine gDNA Extraction Kit
Our high-throughput automated genomic DNA extraction kit is based on a simple, magnetic bead-based protocol making it flexible and scalable for laboratories.

Using 50ml of urine, samples are centrifuged and genomic DNA extracted from the cell pellet​.

The quick and easy workflow​ supports manual or automated preparation of 1 – 96 samples in a single batch.

GALEAS Bladder Kit

GALEAS Bladder  kit

Identified by a combination of publicly available data and deep exome sequencing, the probes in the GALEAS Bladder kit target promoter and exonic regions of 23 of the most relevant genes associated with bladder cancer. The somatic mutations covered by the panel have been shown to detect 96% of bladder cancers in over 770 clinical samples. ​

The libraries generated by the kit are compatible with all Illumina sequencers​ and 384 patient/sample indexes ensure that customer can use the GALEAS Bladder kit on the smallest to the largest output sequencers.​ High on-target rates and excellent uniformity of coverage deliver efficient sequencing ensuring the test can be delivered without incurring unnecessary sequencing costs.

GALEAS Analysis Software
GALEAS Analysis Software screenshot
Our cloud-based bioinformatic analysis solution for GALEAS Bladder is included in the panel’s cost and has been purpose-built to allow rapid analysis and reporting.

Providing a simple, clear and concise answer, the GALEAS Bladder report is easy to interpret and requires no specialist knowledge. ​

Analysis with the GALEAS Analysis Software is easily scalable, with no minimum sample numbers and bulk uploads of sequencing data (FASTQ files), allowing from 1 to 384 samples to be analysed at any one time.

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 cohorts1.

Sensitivity Specificity
pTa 86% 86%
T1 95% 86%
T2+ 89% 86%
G1 76% 86%
G2 92% 86%
G3 92% 86%
NMIBC 89% 86%
MIBC 89% 86%
GALEAS Bladder sensitivity compared to cystoscopy and cytology
Figure 1: GALEAS Bladder performance across all stages of bladder cancer and compared to reported sensitivity of cytology and cystoscopy.

 

1DG 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?

Simple end to end workflow for easy implementation

From ready to ship urine collection devices through to secure cloud-based reporting the process is optimized to maximize efficiencies.

Optimized reagents ensure reliability of test results

All reagents associated with the GALEAS Bladder workflow have been developed and optimized to ensure consistent and reliable results.

Flexible throughput offers scalability

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.
GenomeWeb-Nonacus Webinar - Validation of a non-invasive urine-based NGS bladder cancer test
Find out more about the research behind the development of GALEAS Bladder.

Product Resources

GALEAS Bladder Datasheet [PDF]
GALEAS Bladder Urine Collection Kit [PDF]
GALEAS Bead Xtract Urine gDNA 96 Samples Protocol  [PDF]
GALEAS Bladder Protocol [PDF]
GALEAS Bladder Test Software [PDF]
Nonacus 1-384 UMI Adapters Plate Format [Excel]
What is GALEAS Bladder? [PDF]
Molecular testing across the bladder cancer patient pathway [PDF]
From sample to report; an end-to-end solution for bladder cancer testing [PDF]

Ordering Information

Product Description Pack Size Catalogue Number
GALEAS Urine Collection Device 1 NGS_GAL_UCD
GALEAS Bead Xtract: Urine gDNA Extraction Kit 96 samples PRE_GAL_BXG_96
GALEAS Bladder Kit A – includes 1-96 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples 96 samples NGS_GAL_BCP_FR_96_A
GALEAS Bladder Kit B – includes 97-192 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples 96 samples NGS_GAL_BCP_FR_96_B
GALEAS Bladder Kit C – includes 193-288 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples 96 samples NGS_GAL_BCP_FR_96_C
GALEAS Bladder Kit D – includes 289-384 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples 96 samples NGS_GAL_BCP_FR_96_D
GALEAS Bladder Validation Control Kit 48 NGS_GAL_GBVC_48
Thank you for your interest in GALEAS Bladder
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.