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FDA: NephroCheck Test Approved to Predict Kidney Injury Risk

Screens for decline of kidney function within 12 hours

FRIDAY, Sept. 5, 2014 (HealthDay News) -- The NephroCheck test, designed to predict the risk of sudden kidney injury within 12 hours, has been approved by the U.S. Food and Drug Administration.

Current tests can only determine whether critically ill people already have an acute kidney injury, the agency said Friday in a news release. The new test detects the presence of insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases in the urine. Within 20 minutes, a score based on the amount of the proteins found in the urine can help predict a patient's risk of developing acute kidney injury within 12 hours of being tested.

The new test was evaluated in two clinical studies involving more than 500 critically ill people at 23 hospitals. It accurately predicted 92 percent of acute kidney injury cases in one study and 76 percent in the other, although it also incorrectly gave a positive result in about half of people without acute kidney injury, the FDA said.

"Early assessment and timely treatment for acute kidney injury can help prevent kidney damage and potential associated complications," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement. "The NephroCheck provides health care providers with a quick, validated method of assessing a patient's acute kidney injury risk status which may inform patient management decisions."

The NephroCheck test system is produced by Astute Medical, based in San Diego.

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