China-based AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing, has announced the initiation of a registrational clinical study for its urothelial carcinoma (UC) early diagnostic product UriFind in the United States, alongside the enrollment of the first patient. The study aims to verify UriFind’s performance and support the filing for premarket approval (PMA) with the US FDA.
Study Details
The prospective study is expected to enroll more than 1,000 patients and will be conducted across 10 central urological departments and 3 CAP/CLIA double-certified laboratories. The results will provide critical data for the PMA application, highlighting UriFind’s potential as a non-invasive alternative to the current standard of care.
UriFind Profile
UriFind offers a non-invasive, painless, and low-risk method for detecting bladder cancer by performing methylation detection on the DNA of exfoliated cells in urine. This approach contrasts with the current gold standard of UC clinical diagnosis, cystoscopy, which is invasive, painful, and prone to complications. UriFind has already received a breakthrough therapy designation (BTD) in the US in July 2021, priority review status in China in August 2022, and a CE certificate in the European Union (EU). The product has also completed registrational trials in China.
Company Profile
Established in 2015, AnchorDx is headquartered in Guangzhou and specializes in developing next-generation sequencing (NGS)-based diagnostic products. Its portfolio currently covers approximately 70% of all high-incidence cancers, positioning the company as a leader in the development of innovative diagnostic solutions.-Fineline Info & Tech
