Baxter and BioMérieux in Exclusive Distribution Pact for AKI TestBaxter and BioMérieux in Exclusive Distribution Pact for AKI Test

Both companies will share in-country commercialization, while bioMérieux will retain control over the regulatory approval process.

Omar Ford

September 16, 2020

1 Min Read
IMG_Sep162020at15311PM.jpg
onephoto-stock.adobe.com

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.

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like