Ortho-Clinical Diagnostics announces availability of NEPHROCHECK Test System for AKI patients

Early knowledge of AKI risk may prompt closer patient monitoring and help prevent permanent kidney damage or death

Ortho-Clinical Diagnostics, Inc. today 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.

“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”.

AKI is a common, costly and potentially fatal complication in hospitalized patients. In comparing patients with AKI to patients without AKI, hospital and the intensive care unit (ICU) lengths of stay double, as do costs of care and readmission rates. Moreover, death rates at one year are higher among patients with AKI alone, compared to those patients with heart attack alone.

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. In clinical studies, the NEPHROCHECK^® Test identified the majority of patients that developed moderate to severe AKI within12 hours of assessment.

“The availability of a test to identify patients at risk of developing moderate to severe acute kidney injury can allow for the recognition and closer management of these patients,” said Dr. Kianoush Kashani of the Mayo Clinic. “A test designed to achieve high sensitivity, such as the NEPHROCHECK^® Test, allows for the identification of the majority of patients at risk for developing moderate to severe acute kidney injury.”

The NEPHROCHECK^® Test result, called the AKIRisk™ Score, has significant ability to distinguish patients with AKI from those without AKI. Based on results from clinical studies, patients with a positive AKIRisk™ Score (greater than the cutoff of 0.3) have a one in four to a one in three chance of developing moderate or severe AKI within 12 hours of assessment.

To calculate the AKIRisk™ Score, the NEPHROCHECK^® Test System measures the concentrations of two urinary biomarkers using the ASTUTE140^® Meter. The two novel biomarkers -- tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor binding protein 7 (IGFBP-7), are thought to be involved in G1 cell cycle arrest in the earliest phases of injury.

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,” said Robert Yates, Ortho Clinical Diagnostics’ Chief Operating Officer. “Ortho Clinical Diagnostics is focused on bringing targeted solutions to our customer that address unmet clinical needs and drive improvements to quality care.”