AnchorDx announced today that it enrolled the first patient in its UriFind bladder cancer assay clinical trial in the U.S.
Guangzhou, China-based AnchorDx’s multi-center, prospective trial includes more than 1,000 patients. It tests the non-invasive, quantitative real-time PCR assay in targeted patients. AnchorDx expects the trial to include about 10 sites of urology clinics and three CAP/CLIA laboratories.
The company designed the assay to detect two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer. In July 2021, the FDA granted the assay breakthrough device designation.
AnchorDx plans to use the results of the trial to move toward meeting the requirements for premarket approval in the U.S. The company said its assay’s performance showed improved sensitivity and specificity over cytology and other assays. It can detect early, micro, residual and recurrent bladder cancer. The company said it provi…