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BioMérieux Gets FDA Clearance for Kidney Stress Assay

NEW YORK — BioMérieux said on Thursday that its Nephrocheck kidney stress assay has been cleared by the US Food and Drug Administration.

Nephrocheck detects kidney stress prior to damage when a timely intervention can still make a difference, according to BioMérieux. It is meant to be used in conjunction with a clinical evaluation to assess an individual's risk of moderate or severe acute kidney injury. The test detects two urinary biomarkers: TIMP-2, or tissue inhibitor of metalloproteinases-2, and IGFBP-7, or insulin-like growth factor-binding protein 7.

The test is FDA-cleared for use on BioMérieux's Vidas automated immunoassay system and its Astute140 meter. It is slated for US launch in 2023.

In early 2021, Marcy l'Etoile, France-based BioMérieux received CE marking for the Nephrocheck assay.