Astute Medical, Inc., has received 510(k) clearance through the Food and Drug Administration's (FDA) de novo classification process for its first biomarker-based immunoassay, the NephroCheck Test System, a novel test used to assess risk for acute kidney injury (AKI). This clears the path to for the company to commence U.S. sales in the coming weeks with its strategic partner, Ortho-Clinical Diagnostics, Inc.
The NephroCheck Test System will introduce new information into the patient assessment process, helping physicians establish which patients are at risk for moderate to severe AKI. It 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 acute kidney injury. Within 20 minutes, the system 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. The biomarkers were discovered and validated through large multicenter clinical studies.
The Astute Medical NephroCheck Test System is intended to be used in conjunction with clinical evaluation in patients who are 21 or older, have or have had within the past 24 hours acute cardiovascular and or respiratory compromise, and are ICU patients, as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The System consists of the Astute140 Meter, NephroCheck Test Kit, NephroCheck Liquid Controls Kit, and NephroCheck Calibration Verification (Cal Vers) Kit. Learn more about solutions from Astute Medical.Read more