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 provides a sound basis for the diagnosis of bladder cancer.
“The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the U.S,” said AnchorDx CSO Marina Bibikova. “Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high-performing test for the detection of bladder cancer. We are excited to evaluate its ability to inform patient care.”
Where else is the AnchorDx UriFind assay?
AnchorDx completed a clinical trial for UriFind in China and received priority review in August 2022. It also garnered CE mark approval in Europe.
The company aims to accelerate the global marketization effort for UriFind.
“AnchorDx is committed to transform early detection and diagnosis of cancer as we continuously bring our tests into clinical practice through clinical validation” said Jian-Bing Fan, founder and CEO. “We are collaborating with leading urologists world-wide to gain important clinical evidence on the use of our UriFind test. This clinical trial represents an important step towards commercialization of the test in the U.S.”