Urine-Based, Non-Invasive Molecular Test Accurately Detects Bladder Cancer

It has an estimated 84,000 new cases, and 17,300 deaths in the U.S. in 2021. 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. Now, a new study aims to evaluate the performance of a 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.

AnchorDx (Guangzhou, China)'s 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.

AnchorDx has now achieved 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. 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 three CAP/CLIA laboratories.

"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," added 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."

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