FDA approves first-ever kidney injury diagnostic NephroCheck
- The FDA has approved San Diego, CA-based Astute Medical's NephroCheck to assess the risk of moderate-to-severe acute kidney injury (AKI) in critically ill, hospitalized patients.
- Critically ill patients, especially those who are older or have diabetes or high blood pressure, are most at-risk for AKI.
- Until now, there was no diagnostic for assessing AKI risk.
NephroCheck represents a diagnostic breakthrough for healthcare professionals who work in hospital settings. It detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine. The test provides useful information within 20 minutes that let providers know how high a patient’s risk is for developing AKI within 12 hours.
NephroCheck was evaluated through a regulatory pathway used to approve certain low-to-moderate risk medical devices. Although the two clinical studies evaluating NephroCheck demonstrated high levels of accuracy -- in one study, it detected 92% of AKI patients -- it also rendered a false positive for nearly half of patients without AKI. NephroCheck is a step forward in terms of kidney-function diagnostics -- but at this point, it isn't perfect.