MARCH 29, 2023 | COMPANY | NEWS
The urine-based molecular test can quickly and accurately detect bladder cancer and streamline diagnosis, thereby reducing the need for invasive cystoscopies.
Nonacus launched GALEAS® Bladder, a novel test for the non-invasive detection of bladder cancer at the European Association of Urology (EAU) Annual Meeting in Milan on 10-13th March 2023.
GALEAS® Bladder is a novel bladder cancer test providing a non-invasive, sample-to-report, molecular triage for patients with hematuria. The urine-based molecular biomarker, provides a highly sensitive test that can quickly and accurately detect bladder cancer and streamline diagnosis, thereby reducing the need for invasive cystoscopies.
Developed in collaboration with Professor Rik Bryan and Dr Doug Ward at the University of Birmingham UK, GALEAS® Bladder has been validated in over 600 patient samples from 3 UK clinical cohorts. Analyses confirmed the performance of GALEAS® Bladder, showing high diagnostic accuracy (sensitivity >90%, specificity >85%) and good performance 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 regards 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"Our unpublished data also demonstrates that it is possible to use the same mutation panel and Nonacus platform to identify circulating tumor DNA, thus raising the exciting possibility that a single approach can be used throughout the patient pathway."
The novel technology, unique design and analysis suite utilized in GALEAS® Bladder, offers the potential for this test to work across the entire bladder cancer patient pathway, reducing the reliance on invasive cystoscopy and expensive imaging for NMIBC surveillance, as well as hematuria triage.
"We are very excited to launch GALEAS® Bladder," said Chris Sale, chief executive officer at Nonacus. "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".