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# Bladder Cancer Test Gets Breakthrough Status
- URL: https://www.fdaweb.com/bladder-cancer-test-gets-breakthrough-status/
- Published: 2021-07-21T12:00:00.000Z
- Updated: 2026-09-14T17:07:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149752

FDA has granted AnchorDx a breakthrough device designation for UriFind, an early detection test for bladder cancer based on urine DNA methylation detection. The test is intended as an alternative to traditional cystoscopy. It is designed to detect bladder cancer through random urine collection and conducting methylation detection of exfoliated cell DNA in the urine.

“The performance of the test has shown to be as strong as that of cystoscopy, and significantly better than exfoliative cytology and fluorescence in situ hybridization in the detection of early and non-muscle invasive bladder cancer,” the company says.

The test demonstrates increased advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer, according to the company. The designation is based on data showing the test’s accuracy, sensitivity and specificity at 89.3%, 87.4% and 91.5%, respectively.

Currently, the company is planning a clinical trial in the U.S. to obtain data to support a marketing authorization.