On November 23, 2022 AnchorDx, a world-leading developer of cancer early detection solutions, reported 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 (Press release, AnchorDx, NOV 23, 2022, View Source [SID1234624406]). 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.
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Bladder cancer is a common type of cancer with a high recurrence rate. It has an estimated 84,000 new cases, and 17,300 deaths in the U.S. in 2021 (American Cancer Society). The majority (>90%) of bladder cancer cases are urothelial carcinomas. Cystoscopy, followed by biopsy of suspicious lesions, remains the gold standard for diagnosis of both new and recurrent bladder cancer. However, the approach is highly invasive and costly, due to which bladder cancer is being called the most expensive single cancer. In addition, urine cytology and other methods have poor performance as compared with cystoscopy. 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.
"The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the U.S. Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high performing test for detection of bladder cancer. We are excited to evaluate its ability to inform patient care" said Marina Bibikova, Chief Scientific Officer of AnchorDx.
"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 Chief Executive Officer. "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."
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.
Additional information about the UriFind assay clinical trial is available on clinicaltrials.gov.