Agreement gives Ortho expanded distribution rights in
Europe for the NephroCheck Test on
the Astute140 platform
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.
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.
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