Date: 2015-01-22
Type of information: Development agreement
Compound: NephroCheck® Test
Company: bioMerieux (France) Astute Medical (USA - CA)
Therapeutic area: Kidney diseases - Renal diseases - Diagnostic
Type agreement: development
Action mechanism: 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). 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.
Disease: acute kidney injury
Details: * On January 22, 2015, bioMérieux, 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, announced that they have signed a global, semi-exclusive agreement regarding the development of a test for the early risk assessment of acute kidney injury (AKI). Through this worldwide agreement, Astute Medical grants bioMérieux a license to develop, produce and market the NephroCheck® Test for use on its immunoassay system range VIDAS®, miniVIDAS® and VIDAS® 3. Astute Medical’s NephroCheck® Test received 510(k)-clearance through the FDA’s de novo classification process in September 2014. The test was CE-marked in 2012 and is available in Europe.
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