AnchorDx, a world-leading developer of cancer early detection solutions, announced the first patient enrollment for the UriFind bladder cancer assay clinical trial in the U.S., an over 1,000-patient multi-center, prospective testing of the assay in the targeted patients. This prospective, registrational study is aimed to evaluate the performance of the non-invasive, quantitative real-time PCR (qPCR) assay designed to detect two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer. In July 2021, the assay was granted a Breakthrough Device Designation (BTD) by the U.S. Food and Drug Administration (FDA). Results of this clinical trial are aimed towards meeting the requirements for an application for a Premarketing Approval (PMA) to the FDA in the U.S. The trial is expected to include about 10 sites of Urology clinics and 3 CAP/CLIA laboratories.
UriFind is a urine-based, non-invasive molecular test for accurate detection of bladder cancer. The performance of the UriFind test has shown to provide improved sensitivity and specificity over cytology and other assays. It offers advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer.
At present, UriFind has completed the registered clinical trial in China and was granted a priority review in August 2022 by the China National Medical Products Administration (NMPA) because of its clinical superiority. It has also gained EU CE certification. As an innovative biotechnology enterprise in China with a global perspective, AnchorDx is making every effort to accelerate the global market authorization of UriFind, with a goal to serve more people in need.
