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FDA Clears Ortho's Insulin Reagent and Calibrators

NEW YORK (360Dx) – Ortho Clinical Diagnostics today announced the US Food and Drug Administration has cleared the firm's Vitros immunodiagnostic products insulin reagent and calibrators to manage diabetes and pancreatic disorders.

The assay is expected to be commercially available for use on Orthos' Vitros immunodiagnostic and integrated systems in the US in the third quarter, the firm said. The assay can also be used to assess a broad range of metabolic conditions, including pancreatic tumors, liver disease, acromegaly, Cushing's disease, familial glucose-galactose malabsorption and obesity, Ortho said.

Citing statistics from the World Health Organization, the firm said that 9 percent of the world's population ages 18 and older is affected by diabetes. Another 191 million people with diabetes are currently undiagnosed, it added.