GALEAS™ Bladder
A non-invasive NGS-based molecular test for identifying bladder cancer from a urine sampleA non-invasive, sample to report, molecular triage test for bladder cancer
It leverages ultra-sensitive, targeted next generation sequencing (NGS) chemistry to interrogate 451 somatic mutations 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.
Delivers sensitivity and specificity equivalent to cystoscopy for both Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC).
From home sample collection through to bioinformatics and reporting, the process is optimized and streamlined to maximize efficiencies.
GALEAS Bladder can be run in any NGS capable laboratory and automated and scaled according to throughput.
GALEAS Bladder workflow
Returned urine sample is centrifuged and gDNA extracted from cell pellet using Bead Xtract Urine gDNA Extraction Kit
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
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
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 451 somatic mutations covered by the panel have been shown to detect 96% of bladder cancers in over 664 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
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 451 somatic mutations present in over 96% of bladder cancer cases and has been validated using 664 urine samples from three UK clinical cohorts1.
| Sensitivity | Specificity | |
|---|---|---|
| pTa | 87% | 85% |
| T1 | 95% | 85% |
| T2+ | 86% | 85% |
| G1 | 78% | 85% |
| G2 | 91% | 85% |
| G3 | 91% | 85% |
| NMIBC | 90% | 85% |
| MIBC | 86% | 85% |
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
Flexible throughput offers scalability
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 |
GALEAS Bladder is a Laboratory Developed Test (LDT), and not currently CE marked. Plans for future regulatory approvals are underway.