Astute Medical’s NephroCheck™ test has received a CE mark for commercialization in Europe. The cartridge-based sandwich immunoassay test, run on the firm’s Astute140™ Meter, quantitatively measures two validated urinary biomarkers as a risk assessment for acute kidney injury (AKI), and provides results in 20 minutes.
Biomarker firm Astute’s strategy is to first identify clinical opportunities for biomarker discovery through collaboration with the clinical community. The firm then takes a systems biology approach to the discovery process, combining pathway analysis, proteomics, and genomics to identify and validate biomarkers for the disease and target patient population.
Computational techniques are then used to optimize the selection of individual biomarkers and the performance of biomarker panels, prior to undertaking larger, multisite validation studies to confirm and extend data from pilot studies.