Novel test for non-invasive detection of bladder cancer
March 10, 2023: A collaboration between University of Birmingham researchers and liquid biopsy cancer detection and screening company Nonacus, has resulted in a novel test for the non-invasive detection of bladder cancer, which has been launched today at the Annual Meeting of the European Association of Urology.
Called GALEAS® Bladder, the urine-based molecular test can quickly and accurately detect bladder cancer and streamline diagnosis, reducing the need for invasive cystoscopies.
It uses highly sensitive liquid biopsy technology developed by Nonacus in conjunction with a panel of biomarkers developed by Professor Rik Bryan and Dr Douglas Ward from the University’s Bladder Cancer Research Centre, to detect the presence of bladder cancer by finding DNA from tumour cells present in the urine.
The researchers validated the biomarker panel was in over 600 patient samples from 3 UK clinical cohorts, and analyses have confirmed the performance of the test, showing high diagnostic accuracy (sensitivity >90%, specificity >85%) across all grades and stages of bladder cancer.
Professor Rik Bryan said of the launch: "Since 2009, Doug Ward and I have been working on various strategies to accurately and reliably detect bladder cancer from a urine sample. The DNA-based genomic approaches that we have been developing over the last 8 years, with funding from Cancer Research UK and support and expertise from Nonacus, have allowed us to do just that with a test that appears to rival cystoscopy with regard to sensitivity and specificity for the diagnosis of bladder cancer in patients being investigated for hematuria.
Our unpublished data also demonstrates that it is possible to use the same mutation panel and Nonacus platform to identify circulating tumour DNA, thus raising the exciting possibility that a single approach can be used throughout the patient pathway.”
The test has the potential to work across the entire bladder cancer patient pathway, reducing the reliance on invasive cystoscopy and expensive imaging for non-muscle-invasive bladder cancer surveillance and minimal residual disease monitoring, as well as triage for hematuria (blood in urine).
Chris Sale, CEO of Nonacus, said: “We are very excited to launch GALEAS® Bladder. We are striving to develop a suite of meaningful non-invasive tools that can have real impact on the diagnosis and treatment of patients with suspected cancer. GALEAS® Bladder represents the first in this pipeline, helping to improve patients' lives and reducing the burden of cystoscopy on over stretched clinics. “
About the University of Birmingham
The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
About Nonacus
Nonacus is a leading provider of genetic testing products based in Birmingham, UK. The company works with scientists and clinicians to provide a complete workflow for primary tumour and liquid biopsy analysis with the ultimate goal of enabling enhanced care through earlier diagnosis, treatment stratification and monitoring.
Focused on delivering innovative technologies to the genomic healthcare sector through the use of cell-free circulating DNA as a non-invasive diagnostic tool and through the deployment of their advanced liquid biopsy platform, Nonacus strives to enable decentralised, cost effective and cutting-edge cancer genomics and democratise early cancer detection and monitoring globally.
Nonacus’ mission is to enable cutting-edge cancer genetic testing at an affordable cost enabling more cancer patients to benefit from correct therapy selection and through liquid biopsy, MRD monitoring to determine treatment success and detect relapse sooner.
Nonacus was recently announced as one of the top three fastest-growing technology companies in the UK, and the fastest in healthcare. This accolade provides just one example of their drive to democratize non-invasive healthcare, as a growing number of research facilities and laboratories adopt Nonacus’ genetic tests globally.
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.
