FDA approves acute kidney injury test kit

The U.S. Food and Drug Administration has allowed marketing of a new laboratory test that helps determine if certain patients are at risk of developing moderate to severe acute kidney injury within 12 hours of administering the test.

NephroCheck Test, manufactured by San Diego-based Astute Medical, provides a score indicating the patient's likelihood of developing acute kidney injury within the following 12 hours. There are currently no FDA-approved or cleared tests on the market assessing the risk of developing AKI.

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