FDA OKs Astute Medical's Acute Kidney Injury Assay

The U.S. Food and Drug Administration (FDA) announced that it has authorized the marketing of Astute Medical’s Astute NephroCheck test, a first-of-a-kind lab assay to determine whether a patient is at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the test.

Standard lab tests are only capable of determining whether a patient already has AKI. Often, most patients have moderate to severe AKI before the test yields confirmation of the diagnosis. Astute Medical developed NephroCheck to yield results within 20 minutes based on its detection of the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2), both linked with AKI. The urine-based test gives a score based on the amount of detected proteins in correlation with the patient’s risk of developing AKI within 12 hours. The test targets critically ill patients who are most at risk of AKI, including the elderly and those with high blood pressure.

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

AKI is a sudden decline in kidney function following an injury to the organ. The condition is often without early symptoms, making early diagnosis difficult. AKI causes fluid buildup in the body as well as muscle weakness, chest pain, and chronic kidney disease or permanent damage to the kidney.

The FDA approval was supported by positive results from two clinical studies in which the test accurately detected 92 and 76 percent of AKI patients respectively. However, the assay also gave a false positive result in about 50 percent of patients without AKI, the FDA said.

Astute Medical announced a strategic partnership with Ortho-Clinical Diagnostics (OCD) last July for the marketing of NephroCheck in both the U.S. and certain parts of the EU.