NEW YORK ─ BioMérieux on Wednesday announced it has obtained CE marking for its Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury (AKI).
The Nephrocheck test is now available in key European markets, and BioMérieux intends to gradually deploy it in countries that recognize CE marking. Hospitals and private laboratories can run the tests on its Vidas 3 fully automated benchtop immunoassay system, BioMérieux said.
Nephrocheck detects kidney stress prior to damage when a timely intervention can still make a difference, the firm said. It detects two urinary biomarkers ─ TIMP-2, or tissue inhibitor of metalloproteinases-2, and IGFBP-7, or 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. The proteins are specific to kidney stress and unaffected by the usual comorbidities such as sepsis, trauma, chronic kidney disease, or cancer, BioMérieux said.
"Considering the proportion of patients affected each year, AKI represents a significant burden on the functioning of intensive care units and has a huge economic impact on healthcare systems," Pierre Boulud, chief operating officer for clinical operations at BioMérieux, said in a statement.
Marcy L'Etoile, France-based BioMérieux said it is planning a submission for clearance of the kidney stress test to the US Food and Drug Administration in the near future.