Ortho-Clinical Diagnostics, Inc. Introduces the Astute NEPHROCHECK® Test System, a First of its Kind Test 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.

AKI is a common, costly and potentially fatal complication in hospitalized patients.[1] In comparing patients with AKI to patients without AKI, hospital and the intensive care unit (ICU) lengths of stay double,[2],^[3] as do costs of care³ and readmission rates.[4] Moreover, death rates at one year are higher among patients with AKI alone, compared to those patients with heart attack alone.[5]

Identifying risk of AKI is paramount because AKI usually lacks signs and symptoms[6] and can potentially result in irreversible kidney damage if recognition is delayed.1 In clinical studies, the NEPHROCHECK® Test identified the majority of patients that developed moderate to severe AKI within12 hours of assessment.[7],^[8]

“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.[9],^{[10],[11],[12]}

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.”

References:
[1] Lewington AJP, Certa J, Mehta RL Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney Int. 2013;84(3):457-467.
[2] Hobson CE, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and Mortality Associated With Postoperative AcuteKidney Injury. Annals of Surgery. 2014;00:1–8.
[3] Dasta JF, Kane-Gill SL, Durtschi AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23:1970-1974.
[4] Brown JR, Parikh CR, Ross CS, et al. Impact of perioperative acute kidney injury as a severity index for thirty-day readmission after cardiac surgery. Ann Thorac Surg. 2014;97(1):111-7.
[5] Chawla L, Amdur RL, Shaw AD, Faselis C, Palant CE, Kimmel PL. Association between AKI and Long-Term Renal and Cardiovascular Outcomes in United States Veterans. Clin J Am Soc Neprol. 2014;9:1-9.
[6] Ronco C, Ricci Z. The Concept of risk and the value of novel biomarkers of acute kidney injury. Crit Care. 2013;17:117-118.
[7] Kashani et al. Discovery and validation of cell-cycle arrest biomarkers in human acute kidney injury. Critical Care 2013, 17:R25.
[8] Bihorac A, et al. Validation of Cell-Cycle Arrest Biomarkers for Acute Kidney Injury Using Clinical Adjudication. Am J of Respir Crit Care Med. 2014;189(8):932-939.
[9] Devarajan P. Update on mechanisms of ischemic acute kidney injury. J Am Soc Nephrol. 2006;17:1503–20.
[10] Rodier F, Campisi J, Bhaumik D. Two faces of p53: aging and tumor suppression. Nucleic Acids Res. 2007;35:7475–84.
[11] Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004;337:1–13.
[12] Seo DW, Li H, Qu CK, et al. Shp-1 mediates the antiproliferative activity of tissue inhibitor of metalloproteinase-2 in human microvascular endothelial cells. J Biol Chem. 2006;281:3711–21.