Baxter and bioMérieux win CE mark for Nephroclear CCL14

Baxter and Biomérieux today announced CE mark approval for their Nephroclear CCL14 test.

The companies designed the Nephroclear CCL14 test to predict persistent severe acute kidney injury (PS-AKI). It can be used to support timely clinical decision-making and care pathways, according to a news release.

Baxter and Biomérieux plan to launch Nephroclear CCL 14 commercially across western Europe in 2022.

“Baxter is proud to partner with Biomérieux to offer the Nephroclear CCL14 test as an important new diagnostic option to support individualized AKI management that gives every patient the greatest opportunity for recovery,” Reaz Rasul, GM of Baxter’s acute therapies business, said in the release. “We remain committed to advancing purposeful innovation across the care continuum to help reduce complexity and enable efficiencies in critical care, especially as hospitals continue to feel the impact of the COVID-19 pandemic.”

The test provides a precise measurement to help clinicians assess an individual patient’s risk for developing PS-AKI with the CCL14 biomarker able to distinguish patients who will likely develop PS-AKI from those who will not. The test can also help clinicians determine personalized treatment approaches for each patient.

Baxter and Biomérieux previously agreed to develop and distribute the novel AKI biomarker and 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 controls the commercialization strategy.

Baxter is the exclusive distributor of the test in Europe and will be the same in the U.S., pending clearance from the FDA.

“This new step in our collaboration with Baxter further strengthens our innovative diagnostics solutions portfolio for the management of AKI,” Biomérieux COO of Clinical Operations Pierre Boulud said. “True to our public health mission, we bring to the medical community this high-medical-value immunoassay that has the potential to change the current strategy of care for patients suffering from AKI.” MassDevice