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

RARITAN, N.J., March 13, 2017

RARITAN, N.J., March 13, 2017 /PRNewswire/ -- 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.