New Laboratory Test Detects Risk for Acute Kidney Injury

The NephroCheck test detects levels of 2 AKI markers, which can determine whether the condition will progress to moderate or severe injury.

A new laboratory test allows clinicians to determine critically ill patients’ risk of developing acute kidney injury (AKI) in a much shorter time than existing tests do.

Within 20 minutes of administration, the NephroCheck test provides a score based on the presence of 2 AKI markers in a patient’s urine. The test score correlates to the patient’s risk of developing moderate to severe AKI within 12 hours of test administration, according to an FDA press release.

Astute Medical, a San Diego-based company, manufactures the test.

Existing tests only assess whether a patient already has AKI, and the condition often progresses to the moderate or severe stage before test confirmation. The sudden decline in kidney function tends to occur without early signs or symptoms following a kidney injury due to co-existing disease, infection, or other conditions. AKI is a particular risk in patients who are of an advanced age or who have diabetes and high blood pressure.

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

The FDA reviewed 2 clinical studies with more than 500 critically ill participants when assessing NephroCheck. The test accurately detected AKI in 92% of participants in 1 study, and in 76% of participants in the second study, the FDA states. The test gave false-positive results in half of participants without AKI.

The FDA reviewed NephroCheck data using the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to already-marketed devices.