Research & Development
AnchorDx enrols first US patient in UriFind bladder cancer assay clinical trial
24 November 2022 -

AnchorDx, a China-based developer of cancer early detection solutions, announced on Wednesday that it has enrolled its first patient in the UriFind bladder cancer assay clinical trial in the United States.

The more than 1,000-patient multi-centre, prospective registration study is intended to assess the performance of the non-invasive, quantitative real-time PCR (qPCR) assay aimed at detecting two DNA methylation biomarkers in urine specimens from subjects suspected of having bladder cancer.

The United States Food and Drug Administration (FDA) granted a Breakthrough Device Designation (BTD) for the assay in July 2021. Outcomes of this clinical trial are intended to meet the needs for an application for a Premarketing Approval (PMA) to the FDA in the United States. The trial is likely to include around 10 sites of Urology clinics and three CAP/CLIA laboratories.