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Study launches of novel bladder cancer detection test UriFind
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The first patient has been enrolled in a US-based prospective trial of UriFind, a test for the early detection of bladder cancer that is based on urine DNA methylation detection.1
AnchorDx hopes to use the results of the trial to support the submission of an application to the FDA for a Premarketing Approval of UriFind.
AnchorDx, the manufacturer of the device, explained in a press release that the potential clinical and quality-of-life benefit of UriFind is that by only needing a urine sample to assess whether a patient has bladder cancer, the device avoids a cystoscopy, the invasive standard detection option in this setting.1
The registrational study is enrolling patients suspected of having bladder cancer. The overall targeted enrollment is 1000 patients. Using patients’ urine specimens, researchers will evaluate the efficacy of the quantitative real-time PCR (qPCR) assay, which is designed to detect 2 DNA methylation biomarkers. The study will include about 10 urology clinics and 3 CAP/CLIA laboratories.
AnchorDx hopes to use the results of the trial to support the submission of an application to the FDA for a Premarketing Approval of UriFind.
"The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the United States. Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high performing test for detection of bladder cancer. We are excited to evaluate its ability to inform patient care" Marina Bibikova, chief scientific officer of AnchorDx, stated in the press release.
Breakthrough device designation
The FDA previously granted a breakthrough device designation to UriFind.2 The breakthrough designation is intended to accelerate the development and regulatory review of promising devices.
Clinical evidence of the efficacy of UriFind was previously published in the Journal of Clinical Investigation.3 The study results showed that UriFind had an accuracy rate of 86.7%, a sensitivity rate of 90%, and a specificity rate of 83.1%. AnchorDx noted in a press release2 that these rates have increased with the accumulation of real-world data.
The published study findings also showed that UriFind demonstrated greater sensitivity compared with urine cytology and FISH, particularly for the detection of early-stage (64.5% vs 11.8% and 15.8%, respectively), minimal (81.0% vs 14.8% and 37.9%), residual (93.3% vs 27.3% and 64.3%), and recurrent (89.5% vs 31.4% and 52.8%) tumors. The researchers also found that scores from UriFind were better indicators of tumor malignancy burden.
AnchorDx is based in Guangzhou, China. The China National Medical Products Administration is currently reviewing an application for UriFind under a priority review designation, and the assay has also received EU CE certification.1
References
1. AnchorDx Enrolls the First Patient For Its UriFind® Bladder Cancer Assay Clinical Trial in the U.S. Published online November 23, 2022. Accessed December 11, 2022. https://prn.to/3HybhnB
2. AnchorDx's Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns "Breakthrough Device Designation" from FDA. Published online July 21, 2021. Accessed July 21, 2021. https://prn.to/3ixgQ7G
3. Chen X, Zhang J, Ruan W, et al. Urine DNA methylation assay enables early detection and recurrence monitoring for bladder cancer. J Clin Invest. 2020;130(12):6278-6289. doi: 10.1172/JCI139597
