Ortho-Clinical Diagnostics Inc. has started marketing to hospitals the NephroCheckTest System, designed to help health care providers identify patients at risk of developing moderate or severe acute kidney injury within 12 hours of patient assessment. The FDA approved the test, manufactured by Astute Medical, in September.
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 acute kidney injury. 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 two clinical studies evaluating the test’s safety and effectiveness. The two studies compared the clinical diagnoses of more than 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. In both studies, NephroCheck incorrectly gave a positive result in about half of patients without AKI.
Ortho-Clinical Diagnostics Inc. is the exclusive sales agent for Astute Medical’s NephroCheck Test and the Astute140 Meter in the United States and in certain countries of the European Union.