AnchorDx bladder cancer test gets FDA 'breakthrough' designation

By LabPulse.com staff writers

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to AnchorDx's liquid biopsy test for early detection of bladder cancer using urine DNA methylation detection.

The test, UriFind, received the first breakthrough designation granted to a company in China for a liquid biopsy test for bladder cancer detection. The test is as accurate as a cystoscopy and significantly better than exfoliative cytology and fluorescence in situ hybridization (FISH) in detecting early and nonmuscle-invasive bladder cancer, according to the company.


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