Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced the launch of Ortho’s VITROS® Immunodiagnostic Products C-peptide Reagent Pack and Calibrators, which broadens the company’s menu of tests for all aspects of diabetes and other pancreatic disorders. The assay is now commercially available in the U.S. and countries that accept the CE Mark.

The company reports the C-peptide measurement is used in the diagnosis and management of different types of diabetes and related conditions.  C-peptide is produced and secreted by pancreatic beta cells. Its measurement aids in differentiating between type 1 diabetes, type 2 diabetes, Latent Autoimmune Diabetes (LADA) and Maturity Onset Diabetes of the Young (MODY).  It is also used to detect absolute deficiency of insulin[i], [ii].  In conjunction with insulin and glucose results, C-peptide measurement also helps differentiate between factitious hypoglycemia and endogenous hyperinsulinism caused by insulinoma or other disorders.[iii],[iv].

Robert Yates, Ortho’s chief operating officer comments: “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.”  He noted, “Adding C-peptide to Ortho’s VITROS® menu demonstrates our continued commitment to innovation that helps our customers achieve their goals.”

According to the World Health Organization, diabetes affects nine percent of people 18 years or older worldwide.[v]  What’s more, 191 million people with diabetes are currently undiagnosed.[vi]  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.

The launch follows Ortho’s July 2017 global launch of its Insulin assay, joining an existing, comprehensive diabetes menu that includes HbA1c, Glucose, Beta Hydroxybutyrate, BUN/Urea Creatinine and Microalbumin. On a worldwide basis from mid-2014 through the end of 2018, Ortho is on track to bring about 60 new or enhanced assays to market for its customers.

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.