AnchorDx’s UriFind Receives Breakthrough Therapy Designation for Urothelial Carcinoma

China-based Guangzhou AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing, has obtained a breakthrough therapy designation for its urothelial carcinoma (UC) early diagnostic product UriFind. This marks the first such designation for a Chinese product in this category. The urine DNA methylation detection is being fast-tracked for approval in the US, where it will enjoy four years of automatic medical insurance reimbursement once approved for marketing.

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 been included in the “China Bladder Cancer Diagnosis and Treatment Guidelines 2021” and has previously earned an IVDD CE certificate in the European Union (EU). Additionally, AnchorDx has obtained TUV ISO13485 certification in Southern Germany, further validating its quality and compliance standards.

Future Implications
The breakthrough therapy designation for UriFind highlights its potential to transform the early detection and treatment of urothelial carcinoma. With its non-invasive nature and high accuracy, UriFind is poised to become a significant advancement in the field of bladder cancer diagnostics, offering patients a more comfortable and effective alternative to traditional methods.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry