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Pivotal study launched of novel urinary biomarker test for bladder cancer


A pivotal trial is launching in the United States evaluating the novel ADXBLADDER urinary biomarker test for bladder cancer, according to Arquer Diagnostics, the developer of the diagnostic.1

The test works by detecting minichromosome maintenance complex component 5 (MCM5) in the urine. According to Arquer, all cancer cells contain MCM5, which is shed into the urine when an individual has a bladder tumor.

The company hopes the data from the trial will support FDA 510(k) device clearance for commercialization in the United States. According to Arquer, it has been nearly 20 years since the FDA has approved a new urine-based test for bladder cancer.

"Clinical trials have demonstrated that ADXBLADDER is a highly accurate test which can help to rule out the presence of bladder cancer quickly and painlessly. It is fantastic to see Arquer Diagnostics continuing to invest in robust studies and, if this leads to FDA approval, it will be an incredibly useful new tool for us to safely and accurately diagnose and monitor our patients," chief investigator of the study, Ashish Kamat, MD, MBBS, professor of Urologic Oncology (Surgery) and Cancer Research at M.D. Anderson Cancer Center, stated in a press release.

The pivotal study is specifically exploring ADXBLADDER as a tool to assist in the monitoring of cancer recurrence in patients with non-muscle invasive bladder cancer (NMIBC). The trial is being conducted by investigators at 13 large urology practices across the United States, and is being managed by the CUSP Group, a Clinical Trials Consortium.

"Enhancing physician and patient ability to accurately evaluate for recurrent bladder cancer, through the simplicity of a voided urine specimen, will improve both the diagnosis and management for bladder cancer patients. The CUSP Group LLC are very pleased to expeditiously facilitate this important trial," the coprimary investigator of the study, Neal Shore, MD, medical director for the Carolina Urologic Research Center, and a founding member of CUSP, stated in a press release.

Previous research published in theJournal of Urology2 demonstrated the potential of ADXBLADDER as a component of the follow-up strategy in patients with NMIBC. The study, which was conducted at 21 clinical sites in Europe, included 1431 patients. The researchers found that the assay successfully ruled out the presence of the most aggressive tumors, achieving a negative predictive value of 99%.

“The test has also been shown to detect twice as many tumors as cytology in recurrence monitoring,” Arquer reported in the press release.

ADXBLADDER was previously approved for use across Europe.


1. Arquer Diagnostics' ADXBLADDER Becomes First Bladder Cancer Urine Test To Undergo Rigorous Clinical Trials In USA. Published online July 27, 2021. Accessed July 27, 2021. https://prn.to/3l2QUUg.

2. Roupret M, Gontero P, McCracken SRC, et al. Diagnostic accuracy of MCM5 for the detection of recurrence in nonmuscle invasive bladder cancer followup: a blinded, prospective cohort, multicenter European study. J Urol. 2020;204(4):685-690. doi: 10.1097/JU.0000000000001084

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