Astute Medical has obtained CE mark for a new risk assessment tool, designed for patients with acute kidney injury (AKI).
The new immunoassay test, NephroCheck, enables large and small hospital laboratories to use two newly validated urinary biomarkers for assessing risk in critically ill patients who may develop AKI.
The assay features a single-use cartridge and a Astute140 Meter, which converts the fluorescent signals for each specific novel biomarker into concentrations and combines them into a single numerical test result.
The test, which run using a human urine sample and multiple levels of controls, provides results with in 20 minutes.
The company said failure to recognize and manage AKI in the early stages can lead to devastating outcomes for patients and increased costs to the healthcare system.
Astute Medical chief executive officer Chris Hibberd said AKI is common and can impose significant cost in hospitals.
"Our research suggests that intensivists and nephrologists are eager for new tools that can be used in combination with existing guidelines to advance both the management of patients, and the possibilities of their recovery," Hibberd added.
The company said that the immunoassay test and the Astute140 Meter are not available for sale in the US.