Baxter International has signed an exclusive distribution agreement with bioMérieux for the NEPHROCLEAR CCL14 diagnostic test in both Europe and the U.S. The product is an acute kidney injury (AKI) diagnostic.
As part of the agreement, both companies will share in-country commercialization, while bioMérieux will retain control over the regulatory approval process. The companies didn’t disclose financial terms of the agreement.
“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 release.
A recent study published in Intensive Care Medicine found that urinary CCL14 (C–C motif chemokine ligand 14), the novel biomarker measured by the NEPHROCLEART 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).
The multi-center international prospective observational study, titled “Identification and validation of biomarkers of persistent acute kidney injury: the RUBY study,” enrolled 364 patients in the intensive care unit with moderate or severe AKI (KDIGO stage 2 or 3), of whom 331 were available for the primary analysis. In the analysis cohort, 110 patients (33%) met the criteria for persistent stage 3 AKI.
Study investigators found the CCL14 biomarker had an AUC (95% CI) of 0.83 (0.78–0.87),6 which can be considered excellent and was significantly (p<0.05) greater than values for the other biomarkers tested.