Baxter and in vitro diagnostics company bioMérieux have received CE Mark for the NEPHROCLEAR CCL14 Test designed for persistent severe acute kidney injury (PS-AKI) prediction.
An automated immunofluorescence assay, the NEPHROCLEAR CCL14 Test is developed for use on the ASTUTE140 Meter for measuring C-C motif chemokine ligand 14 (CCL14) in human urine.
It is designed to be used together with clinical evaluation in adults with moderate or severe (Stage Two or Three) acute kidney injury (AKI) and who are hospitalised for an acute illness or condition.
The new test helps clinicians by providing a precise measurement of CCL14, allowing assessment of the patient’s risk for developing PS-AKI.
bioMérieux clinical operations chief operating officer Pierre Boulud said: “This new step in our collaboration with Baxter further strengthens our innovative diagnostics solutions portfolio for the management of AKI.
“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.”
The NEPHROCLEAR CCL14 Test helps in identifying high-risk patients, managing AKI, improving care pathways and guiding proper treatment.
The device helps healthcare providers to determine personalised treatment for each patient, including the need for appropriate interventions and level of care, according to the kidney disease improving global outcomes (KDIGO) clinical practice guidelines.
The patient may be triaged to a higher level of care when found to be at increased risk for PS-AKI.
Furthermore, Baxter and bioMérieux plan to commercially launch the test next year in western Europe.
Last September, the US Food and Drug Administration (FDA) granted De Novo authorisation for Baxter International’s new dialysis membrane, Theranova.