Ortho Clinical Diagnostics Release: New NephroCheck Test Outcomes Data Show Significant Reduction In Kidney Injury, Hospital Stay

Published: Sep 26, 2017

RARITAN, N.J., Sept. 25, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, has announced that health and cost outcomes data from the BigpAK trial in acute kidney injury (AKI) risk assessment and management using the NephroCheck® Test will be presented at this year's European Society of Intensive Care Medicine (ESICM) annual meeting, being held in Vienna, Austria, from September 23-27.   

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The presentation, "Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK study," will be presented by Ivan Göcze, MD on Monday, September 25, 2017 at 9:55 a.m. in the Glasgow Room at the Austria Centre.

AKI is a frequent complication in patients undergoing major surgery, which causes as many as two million deaths worldwide1 and increased health care costs.2  Although the complication can be managed, today's standard indicators of AKI, such as elevated levels of serum creatinine, may not be present until after kidney damage has occurred.3

"The NephroCheck Test will play a vital role in preventing the development of AKI in post-surgical patients," said Fernando Chaves, M.D., chief medical officer at Ortho Clinical Diagnostics, which has developed the VITROS® NephroCheck Test for use on Ortho's VITROS® platforms.  "Ortho is proud to be working to bring this vitally important test to as many ICU patients as possible."   

The randomized BigpAK trial, published earlier this month online in Annals of Surgery,4 utilized the NephroCheck Test to identify patients at high risk of developing AKI, and implement preventative intervention.  Use of the NephroCheck Test, combined with guided therapy, led to a 66 percent reduction in moderate and severe AKI following noncardiac surgery. In addition to the health outcomes, patients in the intervention group spent fewer days in the intensive care unit (ICU), and a reduction in length of hospital stay by five days.

The findings add to the evidence gathered in a trial published earlier this year in the journal Intensive Care Medicine,5 in which the NephroCheck Test was used to evaluate patients after cardiac surgery, resulting in a 33.9 percent reduction in moderate to severe AKI.

Ortho's VITROS® NephroCheck received CE Mark earlier this year.  The company has filed for approval of VITROS NephroCheck in the U.S. Ortho sells the NephroCheck Test on both the VITROS® automated platform and the Astute140 benchtop device.

About The VITROS® Systems
The VITROS® Chemistry, Immunodiagnostics and Integrated Systems from Ortho Clinical Diagnostics is a portfolio of products and patented enabling technologies that help clinical laboratories diagnose, monitor and treat disease.  VITROS® Products are engineered to help clinical laboratories with organizational, operational and economic challenges.

About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 100 countries, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.

The NephroCheckTest Intended Use (United States)
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 intensive care unit (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.

For more information on the NephroCheck Test visit NephroCheck.com.

Astute Medical®, the AM logo, Astute140®, NephroCheck®, the NephroCheck® logo, and AKIRisk® are registered trademarks of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see AstuteMedical.com/about/intellectualproperty.

© Ortho Clinical Diagnostics 2017

1 Ronco C, Ricci Z. Critical Care. 2013;17:117.

2 Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.

3McCullough PA, Shaw AD, Haase M, et al. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup statements from the tenth Acute Dialysis Quality Initiative Consensus Conference. Contrib Nephrol. 2013;182:13-29.

4 Göcze I, Jauch D, Götz M, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery: the prospective randomized BigpAK Study. Ann Surg. Published online August 2017. 

5 Meersch M, Schmidt C, Hoffmeier A, et al.  Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. 2017 Jan 21.

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SOURCE Ortho Clinical Diagnostics

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