FDA Approved Test to Predict Acute Kidney Injury

The FDA has approved the marketing of NephroCheck, a first-of-its-kind laboratory test to identify whether critically ill patients are likely to develop moderate to severe acute kidney injury (AKI).

The test is able to identify the likely risk of kidney injury within 12 hours by detecting insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine.
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After 20 minutes, the test provides a score of the patient’s risk of developing AKI based on the levels of proteins found. Early detection of the likeliness to develop AKI will help practitioners better monitor and prevent kidney damage or death.

The test’s safety and effectiveness were examined in 2 clinical studies involving over 500 critically ill participants at 23 hospitals. NephroCheck accurately identified risk of AKI in 92% in one study and 76% in the other. In both studies, NephroCheck incorrectly gave positive results in about half the patients without AKI.

—Michael Potts

Food and Drug Administration. FDA allows marketing of the first test to assess risk of developing acute kidney injury [press release].  September 5, 2014.  www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412910.htm. Accessed September 8, 2014.