bioMerieux and Astute Medical to Co-Develop NephroCheck Assay to Assess Risk of Acute Kidney Injury

bioM‚rieux, a world leader in the field of in vitro diagnostics, and Astute Medical, a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers, have announced an agreement regarding the development of a test for the early risk assessment of acute kidney injury (AKI). This innovative test, known as the NephroCheck Test, detects the presence of two biomarkers: TIMP-2 (Tissue Inhibitor Metalloproteinases-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7).

AKI is a major public health threat that is common, costly and potentially fatal in hospitalized patients. Through this worldwide agreement, Astute Medical grants bioM‚rieux a license to develop, produce and market the NephroCheck Test for use on its immunoassay system range VIDAS, miniVIDAS and VIDAS 3.

Today, up to 50% of severely ill patients develop AKI, which can result in prolonged hospital stays, especially in intensive care units, thus leading to higher cost of care.The guidelines published by the foundation Kidney Disease Improving Global Outcomes (KDIGO) recommend that patients be assessed for risk of AKI to protect their kidney function. Current methods for risk assessment are insufficient, thereby placing substantial numbers of patients at serious risk of complications and death.

Claudio Ronco, MD, of St. Bartolo Hospital in Vincenza, Italy said: “AKI may present the gravest risk for critically ill patients. It is a serious disorder, not only because of its immediate effect on costs and outcomes in the acute setting, but also because of its profound impact on society in the form of devastating and costly chronic kidney disease complications. Expanding access to new predictive tools for AKI risk assessment can help physicians identify and manage patients susceptible to this prevalent, costly and deadly condition.”

To validate TIMP-2 and IGFBP-7 as biomarkers for AKI risk assessment, Astute analyzed the biomarkers in two rigorous company-sponsored, multicenter, observational clinical studies. In these studies, the NephroCheck Test identified the majority of patients manifesting moderate or severe AKI within 12 hours of assessment.