Ortho-Clinical Diagnostics introduces test system to assess risk for acute kidney injury

Ortho-Clinical Diagnostics, Inc., has announced the nationwide availability to hospitals of the NEPHROCHECK Test System, designed to help healthcare providers identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. Identifying risk of AKI is paramount because AKI usually lacks signs and symptoms and can potentially result in irreversible kidney damage if recognition is delayed.

The NEPHROCHECK Test System detects the presence and measures the concentration of insulin-like growth-factor binding protein 7 (IGFBP-7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, using the ASTUTE140 Meter. These two novel biomarkers are thought to be involved in G1 cell cycle arrest in the earliest phases of injury and are associated with AKI. The biomarkers were discovered and validated through large multi-center clinical studies.

Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates with the patient’s risk of developing AKI within 12 hours. Patients with a positive NEPHROCHECK AKIRisk Score (greater than the cutoff of 0.3) have a 25 percent to 33 percent chance of developing moderate or severe AKI.

In July 2014, Ortho-Clinical Diagnostics, Inc., entered into a strategic collaboration with Astute Medical, Inc., the developer of the NEPHROCHECK Test System, to become 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.

“NEPHROCHECK provides customers with a simple yet innovative new approach to help healthcare providers assess the risk of acute kidney injury, which leads to poor patient outcomes and increased hospital costs,” says Robert Yates, Ortho-Clinical Diagnostics’ Chief Operating Officer.