The FDA has cleared for marketing the NephroCheck test, a first-of-a-kind laboratory test to identify critically ill hospitalized patients at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following administration of the test.
“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, said in an FDA 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.”
NephroCheck detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with AKI. Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being 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’s review included 2 clinical studies evaluating the test’s safety and effectiveness. The studies compared the clinical diagnoses of more than 500 critically ill subjects at 23 hospitals to NephroCheck test results, according to the release. NephroCheck accurately detected 92% of AKI patients in 1 study and 76% in the other. In both studies, NephroCheck incorrectly gave a positive result in about half of patients without AKI.