The Food and Drug Administration (FDA) announced that it has allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to assist in determining if some critically ill hospitalized patients are at risk of developing moderate-to-severe acute kidney injury (AKI) in the 12 hours post-test.
NephroCheck detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2), associated with AKI. The test provides a score within 20 minutes based on the amount of the proteins present correlating to the patient’s risk of developing AKI within 12 hours post-test. It is currently the first FDA-approved or cleared test to assess the risk of developing AKI in at-risk patients.
The FDA decision was based on two clinical studies evaluating the test’s safety and efficacy, which compared clinical diagnoses of over 500 critically ill subjects at 23 hospitals to NephroCheck test results. NephroCheck accurately detected 92% of AKI patients in one study and 76% in the other. NephroCheck incorrectly gave a positive result in about half of patients without AKI in both studies. The data for NephroCheck was reviewed through the de novo premarket review pathway.
For more information visit FDA.gov.