Ortho-Clinical Diagnostics, Inc. Introduces the Astute NEPHROCHECK® Test System, A First of its Kind Test to Assess Risk for Acute Kidney Injury

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

RARITAN, N.J.--()--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.

“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”

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 symptoms6 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.”

About Acute Kidney Injury (AKI)

The kidneys remove waste and help balance fluids and electrolytes in the body. AKI is a sudden loss of kidney function, marked by increases in serum creatinine and decreases in urine output. In hospitalized patients, AKI can develop as a result of sepsis, pneumonia, major or cardiac surgery or drugs that are toxic to the kidneys.

About The NEPHROCHECK® Test System – Important information

The NEPHROCHECK® Test System detects the presence of insulin-like growth-factor binding protein 7 (IGFBP-7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with AKI. Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed. Patients with a positive NEPHROCHECK® 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. The biomarkers were discovered and validated through large multi-center clinical studies.7,8

The NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.

The NEPHROCHECK® Test System consists of the ASTUTE140® Meter, NEPHROCHECK® Test Kit, NEPHROCHECK® Liquid Controls Kit, and NEPHROCHECK® Calibration Verification (Cal Vers) Kit.

For more information about the product, visit www.astutemedical.com

About Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. delivers high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com.

About Astute Medical, Inc.

Named by the Wall Street Journal as one of the Top 10 Healthcare Start-Ups of 2012, Astute Medical is dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers that can serve as the basis for novel diagnostic tests. The Company’s focus is community- and hospital-acquired acute conditions that require rapid diagnosis and risk assessment. Astute Medical’s current areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. For additional information, please visit AstuteMedical.com.

Astute Medical®, the AM logo, ASTUTE140®, NEPHROCHECK® and the NEPHROCHECK® logo are registered trademarks of Astute Medical, Inc. in the United States. AKIRISK™ is a trademark of Astute Medical, Inc. For information regarding trademarks and other intellectual property applicable to this product, please see AstuteMedical.com/US/About/IntellectualProperty.

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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.

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Contacts

Ortho-Clinical Diagnostics, Inc.
Stephanie Scott
Office: 908-218-8137
Cell: 908-720-6859

Release Summary

Ortho Clinical Diagnostics announces the availability of the NEPHROCHECK® Test System designed to help identify patients at risk of developing moderate or severe acute kidney injury (AKI).

Ortho-Clinical Diagnostics, Inc.