The registrational, prospective clinical trial aims to assess the non-invasive assay’s performance in more than 1,000 targeted patients, across multiple sites, including ten Urology clinics and three CAP/CLIA laboratories.
UriFind is a quantitative real-time PCR (qPCR) assay that has been designed for detecting two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer.
The company stated that its urine-based molecular test is intended to accurately detect bladder cancer.
The assay is said to offer superior sensitivity and specificity compared to cytology and other assays, as well as advantages in detecting early, micro, residual and recurrent bladder cancer.
It received Breakthrough Device Designation (BTD) from the US Food and Drug Administration (FDA) in July 2021.
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The company intends to use the results from the clinical trial to support its application for Premarketing Approval (PMA) of the assay from the US FDA.
AnchorDx chief scientific officer Marina Bibikova said: “The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the US.
“Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high-performing test for the detection of bladder cancer.”
Most bladder cancer cases are urothelial carcinomas, and bladder cancer is said to be a common cancer type with a high recurrence rate.
According to the American Cancer Society, nearly 84,000 new cases and 17,300 deaths were reported in the US last year.
AnchorDx said that UriFind completed the registered clinical trial in China and received China National Medical Products Administration (NMPA) priority review in August.
Additionally, the test has received CE certification in the European Union (EU).