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FDA Allows Marketing of First Test to Assess Risk of Developing Acute Kidney Injury

New method may help patient-management decisions

The FDA has approved marketing of the NephroCheck test (Astute Medical), a first-of-its-kind laboratory test to help determine whether certain critically ill hospitalized patients are at risk of developing moderate-to-severe acute kidney injury (AKI) in the 12 hours following administration of the test.

Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.

AKI is a sudden decline in kidney function, often without early signs or symptoms, after an injury to the kidney caused by co-existing disease, infection, or other conditions. AKI can cause fluid build-up in the body, chest pain, muscle weakness, and permanent kidney damage or chronic kidney disease (i.e., the gradual loss of kidney function). Critically ill patients are at greatest risk for AKI, particularly patients who meet certain criteria, such as advanced age, diabetes, and hypertension. Current laboratory tests assess only whether a patient may already have AKI; often, the patient has progressed to moderate-to-severe AKI before the test results confirm the clinical diagnosis.

NephroCheck detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) in the urine; both are associated with acute kidney injury. Within 20 minutes, the test provides a score based on the amount of the proteins present; this score corresponds to the patient’s risk of developing AKI within 12 hours after the test has been performed. No other tests currently on the market are FDA-approved or cleared to assess the risk of developing AKI in at-risk patients.

The FDA reviewed the clinical data for NephroCheck through the de novo premarket review pathway — a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to a currently marketed device.

The FDA’s review included two studies that evaluated the test’s safety and efficacy. Both studies compared the clinical diagnoses of more than 500 critically ill, hospitalized patients with results from the NephroCheck test. The test accurately detected 92% of AKI patients in one study and 76% in the other. In both studies, the NephroCheck test incorrectly gave a positive result in about half of patients without AKI.

“Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications,” said Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “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.”

Source: FDA; September 5, 2014.

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