Ortho Clinical Diagnostics in the News

Ortho Clinical Diagnostics Announces Expansion Of Global Agreement With Astute Medical for NephroCheck Test

March 13, 2017
Agreement gives Ortho expanded distribution rights in Europe for the NephroCheck Test on the ASTUTE140 platform 

Raritan, NJ, March 13, 2017 – Ortho Clinical Diagnostics (“Ortho”), a global leader of in vitro diagnostics, today announced that it has expanded its agreement with Astute Medical, Inc. for distribution of the NephroCheck Test, a biomarker-based test that aids in risk assessment for acute kidney injury. Under the new agreement, Astute Medical has granted Ortho distribution rights in additional European countries, enhancing customer access to a test that is changing the way hospital physicians approach acute kidney injury (AKI), a common and dangerous complication. 

“Ortho is committed to helping our lab customers identify patients with risk for moderate to severe AKI, which has been shown to help physicians to better manage their critically ill patients and improve outcomes,” said Alex Socarrás, Ortho’s executive vice president, commercial operations.  “We look forward to bringing the important NephroCheck Test to a broader market in Europe.”

Today, up to 50 percent of severely ill patients develop AKI, which can result in prolonged hospital stays, long-term complications, greater risk of mortality, and higher cost of care. An outcomes study published recently by the journal Intensive Care Medicine reported a 33.9 percent reduction in the occurrence of moderate to severe AKI following cardiac surgery when clinicians used the NephroCheck Test to identify patients with moderate to severe risk for AKI and then implemented a bundle of care recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.

“As the body of evidence demonstrating the value of assessing kidney stress before damage occurs continues to grow, we become ever more committed to distributing the NephroCheck Test to a broad audience,” said Ryan Roberts, Astute Medical’s chief commercial officer.  “Our expanded agreement with Ortho will help even more hospitals shift the AKI paradigm from diagnosis to prevention.”  

The new agreement builds upon Astute Medical’s licensing and collaboration agreements with Ortho. In 2014, Astute Medical granted Ortho a license to develop and market the NephroCheck Test for Ortho’s VITROS® line of automated, high-volume testing platforms in the United States and certain countries in Europe.  Ortho also commercializes Astute Medical’s NephroCheck Test on the ASTUTE140 platform in the United States.


Important Information About The NephroCheck Test
In the 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 visit NephroCheck.com

In the EU, the NephroCheck Test result is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck Test is CE-marked and available in Europe.

Astute Medical’s NephroCheck Test received 510(k)-clearance through the FDA’s de novo classification. The test is indicated for prescription use only.

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 120 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.

About Astute Medical, Inc.
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. 

Astute Medical is a founding corporate partner of 0by25, a human rights initiative aimed at eliminating preventable and treatable deaths from AKI worldwide by 2025. 

For additional information, please visit AstuteMedical.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

Media Contact
Jane Ward
Jane.ward@orthoclinicaldiagnostics.com
908-210-0118