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BioMérieux, Baxter Get CE Mark for Acute Kidney Injury Test

NEW YORK – BioMérieux and Baxter announced on Thursday that an assay to detect acute kidney injury has obtained the CE mark. The assay detects a biomarker called C–C motif chemokine ligand 14, or CCL14, and was developed in partnership by the two firms, who said they intend to launch the test commercially in Western Europe next year.

Called the Nephroclear CCL14 Test, the assay detects the CCL14 biomarker in urine samples by using an automated immunofluorescence assay on BioMérieux's Astute140 instrument. The biomarker enables prediction of persistent severe acute kidney injury, otherwise known as PS-AKI, and results can be used to support clinical decision making, the firms said.

Both companies will provide support at the customer site for the Nephroclear CCL14 Test, while BioMérieux retains control over the regulatory approval process and Baxter retains control over the commercialization strategy. Baxter is BioMérieux's exclusive distributor of the Nephroclear CCL14 test in Europe and will also be the exclusive distributor in the US pending clearance from the US Food and Drug Administration.

Reaz Rasul, general manager of Baxter’s Acute Therapies business, said in a statement that the test is an "important new diagnostic option to support individualized AKI management," adding that Baxter wishes to "help reduce complexity and enable efficiencies in critical care."

Pierre Boulud, chief operating officer of clinical operations at BioMérieux, called the CE marking a new step in his firm's collaboration with Baxter that "further strengthens our innovative diagnostics solutions portfolio for the management of AKI."

The firms initially announced their collaboration in 2019, noting that the tests under development would incorporate technologies from the Astute Medical business that BioMérieux had then recently acquired, namely the Nephrocheck assays, which BioMérieux has also been positioning as useful for guiding sepsis treatment.