COMPANY:

AnchorDx

"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."

“AnchorDx, a world-leading developer of cancer screening and early detection solutions, together with renowned experts from a top-tier hospital in China…The new diagnostic model is based on circulating cell-free DNA-based (cfDNA) methylation patterns. It can serve as a reliable approach for the early diagnosis of breast cancer and is expected to compensate for the deficiency of mammography…The model yielded a sensitivity of 94.79% and a specificity of 98.70% for differentiating malignant disease from normal lesions (AUROC = 0.9815, and AUPRC = 0.9800), and had better diagnostic power than that of using mammography (AUROC = 0.9315, and AUPRC = 0.9490). As a result, the cfDNA methylation model for breast cancer diagnosis showed increased performance over mammography.”

"AnchorDx...announced the completion of a USD 40 million Series C financing....AnchorDx plans to use the new funds to accelerate the registration and commercialization of its NGS-based products for single-cancer, multi-cancer, and pan-cancer screening and early detection. The company also plans to deploy its technology to other major disease areas."

"The benchmark medical UriFind® Bladder Cancer Detection Kit has superior diagnostic performance, with a sensitivity of 90.0%, a specificity of 83.1%, and an accuracy of 86.7%. It is equivalent to the performance of a cystoscope and is superior to the bladder cancer methylation detection that has also obtained the EU CE certification. product. At the same time, UriFind® detection is not limited to morning urine, and shows better diagnostic sensitivity in early non-muscular invasive bladder cancer (NMIBC), recurrence diagnosis, and upper urinary tract urothelial cancer (UTUC)."