A multi-institution study has found evidence that two biomarkers are predictive of acute kidney injury (AKI), or renal failure, yet the test that detects them is still in the approval process in the U.S.

One of the study's authors, University of Florida professor Azra Bihorac, M.D., is currently working with colleagues at the university's college of engineering on a clinical algorithm that can use electronic health records to calculate a patient's risk of developing the condition.

The researchers studied 420 critically ill patients in 23 sites for the presence of tissue inhibitor of metalloproteinases (TIMP)-2 and insulin-like growth factor binding protein 7 (IGFBP7). Patients who exhibited a level of 0.3 (ng/ml)2/1000 or more of the two biomarkers were seven times more likely to develop acute kidney injury as patients with the biomarkers below that threshold.

The study, published online in the American Journal of Respiratory and Critical Care Medicine, was funded by San Diego-based Astute Medical to validate the performance of its NephroCheck Test, which assesses a critically ill patient’s risk of developing AKI. The test has received the CE mark in Europe. The University of Florida article says FDA. 510(k) approval is pending.

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