AnchorDx, a world-leading developer of cancer screening and early detection solutions, on July 13, 2021, was awarded a Breakthrough Device Designation (“BTD”)[1] by the US Food and Drug Administration (FDA) for UriFind (or “the Test”), an early detection test for bladder cancer based on urine DNA methylation detection. This is the first BTD granted to liquid biopsy test for bladder cancer detection in China.
Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless, and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine. The performance of the Test has shown to be as strong as that of cystoscopy, and significantly better than exfoliative cytology and Fluorescence in situ hybridization (FISH) in the detection of early and non-muscle invasive bladder cancer (NMIBC). The Test demonstrates increased 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 Test’s research achievements have been published in The Journal of Clinical Investigation[2] and Clinical Epigenetics. Following years’ of real-world sample accumulation and verification by AnchorDx, the accuracy, sensitivity and specificity of UriFind have now reached 89.3%, 87.4% and 91.5% respectively. During the FDA-BTD approval process, AnchorDx provided head-to-head experiment results with another internationally approved product, proving the Test’s superior performance in detection sensitivity and ease-of-use.
UriFind’s detection method has been included in the newly released 2021 Guidelines for Diagnosis and Treatment of Bladder Cancer in China and has also gained EU CE marking. In addition, AnchorDx has also passed the medical device quality management system certification – TUV ISO 13485 Certification.
At present, AnchorDx’s UriFind has entered the registered clinical trials stage in China, and clinical trials in the United States will be launched soon. Once the Test obtains the US market authorization from FDA, a four-year national medicare coverage[3] will be provided. As an innovative biotechnology enterprise in China with a global perspective, AnchorDx constantly promotes the registration and certification of advanced cancer early detection technology around the world and is making every effort to accelerate the global market authorization of UriFind, with a view to enabling it to serve more population in need as soon as possible.
[1] Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program
[2] Chen X, Zhang J, Ruan W, et al. Urine DNA methylation assay enables early detection and recurrence monitoring for bladder cancer[J]. The Journal of clinical investigation, 2020 https://doi.org/10.1172/JCI139597
[3] Medicare Coverage of Innovative Technology (CMS-3372-F) https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f