UriFind Test for Bladder Cancer Granted FDA Breakthrough Device Designation

The UriFind test that utilizes DNA methylation detection for the diagnosis of bladder cancer has been granted a breakthrough device designation by the FDA.

The UriFind test that utilizes DNA methylation detection for the diagnosis of bladder cancer has been granted a breakthrough device designation by the FDA, according to a press release by AnchorDx.1

UriFind is a non-invasive test that allows for bladder cancer detection using a urine sample. Cancer is detected using methylation detection of exfoliated cell DNA in the patient’s urine. The test has been shown to be as strong as a cystoscopy and more accurate than exfoliative cytology and fluorescence in situ hybridization (FISH) for the detection of early, non-muscle invasive bladder cancer.1

The designation was granted based on real-world data published in The Journal of Clinical Investigation. The diagnostic model was trained using 313 samples and validated by 175 samples in a multicenter, prospective, independent cohort. Samples were collected from across China. The modeling cohort enrolled 142 patients with urothelial carcinoma, 12 healthy participants, and 159 non-cancer controls between June 2017 and May 2019. In the blinded cohort, 109 patients with bladder cancer and 66 non-cancer controls were included. The surveillance cohort enrolled 38 patients with tumor recurrence and 43 patients without recurrence.2 

The device had a 90% specificity for CpG biomarker cg21472506 and an 83.1% specificity for cg11437784. Compared with the similar device EpiCheck, UriFind was also more sensitive to recurrent bladder-cancer. UriFind has a sensitivity of 75% to low-grade recurrent bladder cancer and 93% for high-grade recurrent bladder cancer. For EpiCheck, the low-grade sensitivity rate if 40% and a high-grade sensitivity rate of 89%. 

“The early-stage, minimal, residual, and recurrent tumors of BCa were very difficult to diagnose, which was usually missed by urine cytology and FISH. However, this method achieved a great improvement in sensitivity over cytology and FISH, serving as a promising solution in these conditions. Importantly, the UD score positively correlated with the grade, stage, size, and the presence of residual and recurrent tumors of BCa. These results make this method attractive for use in clinical decision-making across a variety of patients and situations, and could in turn reduce the current burden of repeated cystoscopy and blind Re-TURBT,” study authors wrote.

REFERENCES:
1.AnchorDx's Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns "Breakthrough Device Designation" from FDA. News release. AnchorDx. July 21, 2021. Accessed July 21, 2021. https://prn.to/3hRIihq
2.Chen X, Zhang J, Rian W, et al. Urine DNA methylation assay enables early detection and recurrence monitoring for bladder cancer. J Clin Invest. 2020;130(12):6278–6289. https://doi.org/10.1172/JCI139597.