Astute gets CE mark for acute kidney injury immunoassay test

15 October 2012 (Last Updated October 15th, 2012 18:30)

The European Union has granted Astute Medical CE mark certification for its risk assessment tool for patients who may develop acute kidney injury (AKI).

The European Union has granted Astute Medical CE mark certification for its risk assessment tool for patients who may develop 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 the Astute140 Meter, a compact platform that converts the fluorescent signals for each specific novel biomarker into concentrations and combines them into a single numerical test result.

Failure to recognise and manage AKI in the early stages can lead to devastating outcomes for patients and increase costs to the healthcare system, according to the company, which claims that the new test would offer results within 20 minutes after it was run using a human urine sample and multiple levels of controls.

Astute Medical chief executive officer Chris Hibberd said AKI 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 said.

The company confirmed that the immunoassay test and the Astute140 Meter are not available for sale in the US.