COMPANY:

AnchorDx

" ...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."

"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."

"AnchorDx said Wednesday that its PulmoSeek lung cancer early detection assay, has received CE marking, with a reagents license issued by the Netherlands' CIBG of Ministry of Health, Welfare, and Sport."