TEST:

UriFind® Methylation Test

No abstract available

" ...the 'Human ONECUT2/VIM Gene Methylation Detection Kit (Fluorescent PCR Method)' (hereinafter referred to as UriFind®) independently developed and produced by Guangzhou Benchmark Medical Co., Ltd. has obtained the National Medical Products Administration (NMPA) III Medical device registration certificate (National Medical Device Approval No. 20243400221)."

"AnchorDx said Monday that it has entered into a long-term collaboration with DiaCarta aimed at product development and global commercialization in the cancer screening space...Under the agreement, AnchorDx and DiaCarta will leverage proprietary technologies for DNA methylation and mutation detection that each company has developed...The firm is currently conducting a registrational and prospective clinical trial for the urine-based assay, dubbed UriFind, and Pleasanton, California-based DiaCarta will serve as one of the clinical testing laboratories."

The performance of UriFind has been extensively validated in this cohort of 2445 cases. With similar specificity and significantly higher sensitivity than urine cytology and FISH, UriFind is a rapid, high-throughput, noninvasive, and promising approach for early diagnosis, minimal residual tumor detection, and surveillance in the whole course management of UC. Its implementation could reduce the burden of cystoscopy and unnecessary second transurethral resection of bladder tumor.

The performance of UriFind is well validated with significantly higher sensitivity and accuracy than urine cytology and FISH in UC detection in this cohort with 2003 cases. This assay facilitates whole course management of urothelial carcinoma, which may reduce the burden of cystoscopy and unnecessary second TURBT. Clinical trial information: NCT04314245.

The performance of UriFind® is well validated with significantly higher sensitivity and accuracy than urine cytology and FISH in UC detection in this cohort with 2003 cases. This assay facilitates whole course management of urothelial carcinoma, which may reduce the burden of cystoscopy and unnecessary second TURBT.

"AnchorDx...announced 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. 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."

Legal entity responsible for the study: Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Funding: AnchorDx Medical Co., Ltd.