FDA grants breakthrough designation to novel bladder cancer detection test

The FDA has granted a breakthrough device designation to UriFind, a test for the early detection of bladder cancer that is based on urine DNA methylation detection, according AnchorDx, the manufacturer of the device.1

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. 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.2 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 release1 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.

“Urine tumor DNA methylation assessment for early diagnosis, minimal, residual tumor detection and surveillance in bladder cancer is a rapid, high-throughput, noninvasive, and promising approach, which may reduce the burden of cystoscopy and blind second surgery,” the authors wrote in their study conclusion.

AnchorDx is based in Guangzhou, China. According to the company, “UriFind's detection method has been included into the newly released 2021 Guidelines for Diagnosis and Treatment of Bladder Cancer in China and has also gained EU CE marking.”

The company plans to soon launch clinical trials of UriFind in the United States.

References

1. 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.

2. 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.