bioMérieux, Marcy l’Etoile, France, announced the CE marking of the NephroCheck assay to detect kidney stress in patients at risk of acute kidney injury (AKI).

AKI is a common complication, affecting between 7% and 18% of all hospitalized patients and up to 50% of critically ill patients. The condition is associated with a 10-fold increase in hospital mortality and a higher rate of chronic kidney disease among post-op patients.

While a number of acute risk factors and patient characteristics have been identified which predispose patients to AKI4, there is no reliable way for a clinician to establish a clear risk profile for any given patient. Delays in recognizing AKI can potentially lead to irreversible consequences. In many cases, adverse patient outcomes are avoidable if the condition is identified and managed in a timely fashion.

NephroCheck is a test that detects kidney stress prior to actual damage, when a timely intervention can still make a difference. It is intended to be used in conjunction with clinical evaluation as an aid to support the risk assessment of moderate or severe AKI in acutely ill patients. With this early information, clinicians may either rule out kidney stress with confidence, or implement a series of protective measures for the kidneys.

The NephroCheck test relies on the detection of two urinary biomarkers: TIMP-2 (tissue inhibitor of metalloproteinases-2) and IGFBP-7 (insulin-like growth factor-binding protein 7). Both proteins are produced by stressed kidney cells as an early warning signal, before the onset of AKI. Specific to kidney stress, they are not affected by any of the usual co-morbidities (such as sepsis, trauma, chronic kidney disease, or cancer).

“As a predictive tool for AKI, NephroCheck provides clinicians with high medical-value information and can lead to benefits in patient care and improved outcomes,” says Mark Miller, executive vice president and chief medical officer, bioMérieux. “The development of this test is consistent with our focus on improving care for individuals with acute medical and critical conditions. It complements our existing pioneering assays for these patients, such as procalcitonin (PCT).”

Effective immediately, Vidas NephroCheck is available in key European markets and will gradually be deployed in countries that recognize CE marking. Hospitals and private laboratories will be able to run the tests on bioMérieux’s Vidas 3 system, which allows for higher throughput, automation, and traceability. bioMérieux is planning a submission for FDA clearance in the near future.

Featured image: Vidas NephroCheck now has the CE mark to be run on bioMérieux’s Vidas 3 system (Courtesy: bioMérieux)