Baxter and bioMérieux Announce CE Mark for NEPHROCLEAR CCL14 Test to Predict Persistent Severe Acute Kidney Injury

Baxter International Inc. (NYSE:BAX), a global leader in acute care, and bioMérieux (EPA:BIM), a global leader in in vitro diagnostics, today announced the CE marking of the NEPHROCLEAR CCL14 Test. The NEPHROCLEAR CCL14 Test is designed to predict persistent severe acute kidney injury (PS-AKI) and can be used to support timely clinical decision-making and care pathways. The companies intend to commercially launch the NEPHROCLEAR CCL14 Test in western Europe in 2022.

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“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,” said Reaz Rasul, general manager of Baxter’s Acute Therapies business. “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.”

“This new step in our collaboration with Baxter further strengthens our innovative diagnostics solutions portfolio for the management of AKI,” said Pierre Boulud, chief operating officer, clinical operations, bioMérieux. “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.”

AKI is a sudden decrease in kidney function over a period of hours to days, often as a result of illness, trauma or infection. The sudden loss of kidney function leads to the accumulation of toxins and fluid in the blood that, if left untreated, may lead to death. Baxter recently collaborated with bioMérieux and Premier Applied Sciences (PAS) to conduct a study assessing the economic and clinical impact of PS-AKI. Data from this study presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) showed that PS-AKI (stage 3 AKI lasting ≥ 3 days) is independently associated with a longer length of stay and higher costs during index hospitalization and 30-day follow-up compared to non-persistent AKI. Additional data from this study, presented at the European Society of Intensive Care Medicine (ESICM) LIVES congress, showed that PS-AKI is prevalent among hospitalized adults in the U.S. and is associated with a significantly higher risk of death during hospitalization, as well as readmissions, dialysis and death during 30-day follow-up, compared to patients without PS-AKI.