NephroCheck Approved by FDA as Acute Kidney Injury Test

A new test recently approved by the US Food and Drug Administration (FDA) could go a long way in helping identify patients who could suffer acute kidney injury (AKI) following hospitalization.

According to a statement from the FDA, NephroCheck can pinpoint patients at risk of “moderate to severe acute kidney injury” in just 12 hours where current tests only serve to diagnose patients with AKI. The statement describes AKI as “a sudden decline in kidney function, often without early signs or symptoms, following an injury to the kidney caused by a co-existing disease, infection, or other condition.”

Patients with AKI can experience symptoms that include “fluid to build up in the body, chest pain, muscle weakness and permanent kidney damage or chronic kidney disease.”

NephroCheck, the statement noted, “detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-s) which are associated with acute kidney injury.”

With no real way previously to predict potentially at-risk patients, many patients with AKI experienced complications from the condition before the diagnostic test results came back.

“Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications,” noted Alberto Gutierrez, director of the Office of In Vitro Diagnostics and

Radiological Health at the FDA 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.”

NephroCheck was approved through the FDA’s de novo premarket review pathway, which is used for low-to moderate-risk devices “that are not substantially equivalent to an already legally marketed device,” the statement said. In two clinical studies involving more than 500 patients at 23 hospitals Nephrocheck detected AKI in 92% of patients in one and 76% in the second. The test “incorrectly gave a positive result in about half of patients without AKI,” the FDA reported.

The test is manufactured by Astute Medical, which is based in San Diego, CA.