Baxter and bioMérieux announce CE Mark for NEPHROCLEAR CCL14 test to predict persistent severe acute kidney injury.
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.
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 greater than 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.
A consensus statement from the Acute Disease Quality Initiative Consensus Conference underscores the importance of new biomarkers like CCL14 (C–C motif chemokine ligand 14), the biomarker measured by the NEPHROCLEAR CCL14 Test, in helping to manage AKI by identifying high-risk patient groups, guiding therapy and improving care pathways. Recent studies published in Intensive Care Medicine,Critical Careand Journal of Thoracic and Cardiovascular Surgery suggest that CCL14 is the most predictive biomarker of PS-AKI when compared with other AKI biomarkers, including NGAL, CHI3L, L-FABP, Cystatin C, Proenkephalin, and KIM-1.
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