Assay will be commercially available in third quarter in
countries accepting CE Mark
RARITAN, New Jersey,
July 21, 2017 /PRNewswire/
-- Ortho Clinical Diagnostics, a global leader of in vitro
diagnostics, today announced that Ortho's VITROS®
Immunodiagnostic Products Insulin Reagent and Calibrators have
received CE Mark, broadening Ortho's menu of tests that
manage all aspects of diabetes and other pancreatic disorders. An
important biomarker in diabetes and pre-diabetes testing, the assay
is expected to be commercially available for use on all of Ortho's
VITROS® Immunodiagnostic and Integrated Systems in
Europe and other countries
accepting the CE Mark during the third quarter of this year.
According to the World Health Organization; diabetes affects
nine percent of people 18 years or older
worldwide.i What's more, 191 million people with
diabetes are currently undiagnosed.ii Diabetes is
managed as a chronic, lifelong condition with several significant
co-morbidities, so it is vital that laboratories have a partner
that supports the continuum of diabetes diagnostics.
"Our goal at Ortho is to provide the broad range of tools health
care providers need to monitor and manage complex metabolic
diseases and conditions like diabetes," said Robert Yates, Ortho's chief operating
officer. "Adding Insulin to Ortho's VITROS® menu
demonstrates our continued momentum in product development."
The VITROS® Insulin Assay is part of Ortho's
VITROS® Systems' comprehensive diabetes menu, which
includes HbA1c, glucose and microalbumin. The
VITROS® Insulin Assay can also help to assess a broad
range of metabolic conditions, including pancreatic tumors, liver
disease, acromegaly, Cushing's disease, Familial Glucose-Galactose
Malabsorption and obesity.
About The VITROS® Systems
The VITROS® Chemistry, Immunodiagnostics and Integrated
Systems from Ortho Clinical Diagnostics is a portfolio of products
and patented enabling technologies which 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 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.
© Ortho Clinical Diagnostics 2017
PR-03010
i http://www.who.int/diabetes/global-report/en/
ii. https://www.idf.org/about-diabetes/what-is-diabetes.html
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