Precision health diagnostics company Nanostics launched a prospective clinical study designed to validate a novel and minimally invasive bladder cancer diagnostic test, ClarityDX Bladder, using its ClarityDX diagnostic platform.

In partnership with the University of Alberta’s Alberta Prostate Cancer Research Initiative (APCaRI) and DynaLIFE Medical Labs, the study will recruit patients at sites in Alberta and Northern Ontario, the company says. Financial support for the study is provided with a $600,000 financial contribution through the Alberta Innovates AICE-Concepts Program. A preliminary 142-patient study with ClarityDX Bladder showed that it could accurately identify patients with bladder cancer compared to healthy individuals.

Bladder cancer is the fifth most prevalent cancer in North America. Roughly 70% of cancer cases of this type are low-grade, noninvasive, non-fatal, recurring tumors requiring life-long surveillance. The remaining 30% are high-grade, aggressive, fatal tumors requiring rapid and intensive treatment. Most cancers of this kind are asymptomatic, making diagnosis and follow-up surveillance a significant challenge.

Currently, bladder cancers are diagnosed using cystoscopy, the gold standard procedure for bladder cancer screening, and monitored with urine cytology tests. Cystoscopy is invasive, uncomfortable, and has limited detection capacity for some forms of bladder cancer. Meanwhile, Nanostics’ ClarityDX Bladder test uses extracellular vesicle detection technology and machine-learning model analysis to identify the most potent disease predictors for the early detection of cancer.

“Strategic investments in digital health are enabling Alberta to become more globally competitive towards increasing health and economic benefits for our province,” says Sunil Rajput, director of research for Health Innovation with Alberta Innovates. “Our AICE-Concepts Program is a strong example of digital health investments to power research towards addressing unmet clinical needs.”

Implementing ClarityDX Bladder as a highly accurate, noninvasive bladder cancer test aims to allow for straightforward diagnosis of low-grade bladder cancers and more rapid detection of aggressive bladder cancer before cystoscopy. This would transform bladder cancer care by making it easier to detect changes in tumor status without cystoscopy and improving active surveillance of bladder cancer patients.

“We are excited to launch our bladder cancer study and thank all the patients for their generous participation in the study,” John Lewis, CEO of Nanostics says, “the detection of early-stage bladder cancer is a critical first step for improving patient outcomes.”

Recently, Nanostics announced positive results from the clinical validation study of its lead prostate cancer diagnostic test, ClarityDX Prostate, showing 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant (grade group ≥2) prostate cancer. Implementation could eliminate up to 37% of unnecessary biopsies and significantly reduce the number of unnecessary treatments for prostate cancer.