Astute Medical Receives FDA Clearance for NephroCheck Test, Begins Prepping US Launch

Sep 12, 2014

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NEW YORK (GenomeWeb) – Astute Medical said this week that it has received US Food and Drug Administration 510(k) clearance for its NephroCheck Test System, a protein biomarker-based test for assessing risk of acute kidney injury.

The San Diego-based company said that it plans to launch US sales of the test in coming weeks through its strategic partner Ortho Clinical Diagnostics, the exclusive sales agent for Nephrocheck.

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