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Ortho Clinical AKI Test Receives CE Mark

NEW YORK (360Dx) – Ortho Clinical Diagnostics today announced the Vitros NephroCheck acute kidney injury test has received CE marking and is available in Europe.

Developed under license from Astute Medical, the test, which previously ran only on the Astute 140 meter, can now be used on Ortho Clinical's fully automated Vitros 3600/5600 Immunodiagnostic Systems. It measures two biomarkers, TIMP-2 and IGFB-7 from urine samples and provides results in 16 minutes, Ortho Clinical said.

In March, Astute and Ortho Clinical inked a distribution deal to expand the number of countries in Europe with access to the test. In 2014, the two companies agreed to a license to Ortho Clinical to develop and market NephroCheck on the Vitros line of automated, high-volume testing platforms.