NEW YORK – Baxter International said on Wednesday that it has inked a distribution agreement with BioMérieux for its Nephroclear CCL14 diagnostic test currently in development for use in assessing the risk of developing persistent sever acute kidney injury (AKI).
Specifically, Baxter will be the exclusive distributor of the assay in Europe and the US following regulatory approval and launch in those markets. The companies will share in-country commercialization, while BioMérieux will retain control over the regulatory process. Financial terms of the agreement were not disclosed.
The distribution agreement builds on a previously announced partnership between the companies to develop biomarkers for the rapid identification of AKI into a diagnostic test.
"Baxter's agreement with BioMérieux will allow us to introduce a new diagnostic offering to our acute therapies portfolio and offer clinicians a meaningful tool as they manage the complexities of AKI in their patients," Reaz Rasul, general manager of Baxter's acute therapies business, said in a statement.
AKI is a potentially life-threatening condition where the kidneys suddenly stop working, often as the result of illness, trauma, or infection, and is an increasingly common complication of acute illnesses in intensive care units and hospitals. The ability to predict persistent severe AKI could help physicians determine which patients are likely to recover on their own and which patients may require more intensive management, including evaluation of renal replacement therapy to replace the function of the kidneys.
A recent study published in Intensive Care Medicine found that urinary CCL14 (C–C motif chemokine ligand 14), the novel biomarker measured by the Nephroclear CCL14 test, is the most predictive of persistent stage 3 AKI, the most severe form of AKI, when compared with other AKI biomarkers (NGAL, CHI3L1, L-FABP, Cystatin C, Proenkephalin, KIM-1 and IL-18).