NGS-based urine bladder cancer test
GALEAS™ Bladder
A non-invasive NGS-based molecular test for identifying bladder cancer from a urine sample
GALEAS Bladder is a simple, sample-to-report urine test to detect the presence of bladder cancer.
GALEAS Bladder 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 alternative to flexible cystoscopy.
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).
Automated and scalable workflow
GALEAS Bladder can be run in any NGS capable laboratory and automated and scaled according to throughput.
Sample to answer solution
From home sample collection through to bioinformatics and reporting, the process is optimized and streamlined to maximize efficiencies.
Part of a suite of products for oncology and liquid biopsy
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
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.
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.1
| 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% |
Figure 1: GALEAS Bladder performance across all stages of bladder cancer and compared to reported sensitivity of cytology and cystoscopy.
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.
Find out more about the research behind the development of GALEAS Bladder
For Research Use Only. Not for use in diagnostic procedures. Plans for future regulatory approvals are underway. Nonacus is responsible for the development and ascertainment of the performance characteristics of GALEAS Bladder.
References
1. Ward DG, Baxter L, Ott S, Gordon NS, Wang J, Patel P, et al. Highly sensitive and specific detection of bladder cancer via targeted ultra-deep sequencing of urinary DNA. European Urology Oncology. 2023 Feb;6(1):67-75.
Click here to see our customer publications
| Product Description | Catalog No. |
| GALEAS Urine Collection Device | NGS_GAL_UCD |
| GALEAS Bead Xtract: Urine gDNA Extraction Kit | 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 | NGS_GAL_BCP_FR_96_A |
| GALEAS Bladder Kit B - includes 1-96 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples | NGS_GAL_BCP_FR_96_B |
| GALEAS Bladder Kit C - includes 1-96 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples | NGS_GAL_BCP_FR_96_C |
| GALEAS Bladder Kit D - includes 1-96 indexes and complimentary analysis of FASTQ files using GALEAS Analysis software for up to 96 samples | NGS_GAL_BCP_FR_96_D |
| GALEAS Bladder Validation Control Kit | NGS_GAL_GBVC_48 |
How has the GALEAS Bladder test been designed and how was it validated?
GALEAS Bladder has been designed to have 4 components:
1) 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.
2) High-throughput genomic DNA extraction kit extracts tumor-derived DNA from urinary cell-pellets using an easily automated magnetic bead-based protocol.
3) Comprehensive gene panel including 23 key genes linked with bladder cancer and somatic mutations found across 96% of bladder cancers.
4) Cloud-based software delivers a simple positive or negative result for the likely presence of bladder cancer.
>700 patient urine samples from 3 UK clinical cohorts were used to validate the test, this incorporated 384 positive bladder cancer cases and 388 negative cases, which showed no signs of cancer at the time of cystoscopy.
GALEAS Bladder was developed in collaboration with Professor Rik Bryan and Dr. Doug Ward from the University of Birmingham UK, in a recent webinar they presented all the details of the design and validation processes – you can watch the webinar on demand now: Validation of a Non-Invasive Urine-Based NGS Bladder Cancer Test webinar.
What genes are tested for using GALEAS Bladder?
The NGS sequencing panel targets promoter and exonic regions of 23 genes in over 96% of bladder cancer cases. These have been identified by a combination of publicly available data and deep exon sequencing. GALEAS Bladder has been validated in over 700 clinical samples.
Could I use cell-free DNA (cfDNA) as well as cell pellet genomic DNA (cpDNA) in the test?
Yes, it should be possible to use cfDNA as well as cell pellet genomic DNA. GALEAS Bladder has been tested and validated using cpDNA, as in the majority of cases the cpDNA will be of higher quantity compared with the cfDNA that is obtained from a urine sample. Therefore it is likely to be easier and more accurate to perform the test using cpDNA.
How long does the uploading and processing of GALEAS Bladder FASTQ's take?
The upload speed depends on the internet connection speeds from a lab, but a typical 96 sample bladder run on average broadband connection will take around 4-6 hours to upload, with the bioinformatics processing taking around 4-5 hours. A notification email will be sent by GALEAS when the results are available to download.
Can the full list of variants in GALEAS Bladder be supplied?
Information about the variants is not available as the information is proprietary. However, a subset of common variants can be supplied on request.