Ortho Clinical Diagnostics Receives FDA 510(k) Clearance for Ortho's VITROS® Insulin Reagent & Calibrators

Assay will be commercially available in third quarter in the U.S.

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Jun 26, 2017, 10:32 ET

RARITAN, N.J., June 26, 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 510(k) clearance from the U.S. Food and Drug Administration (FDA), 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 the U.S. 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 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 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.

i http://www.who.int/diabetes/global-report/en/

ii. https://www.idf.org/about-diabetes/what-is-diabetes.html

SOURCE Ortho Clinical Diagnostics