Ortho Clinical Diagnostics Announces FDA Clearance of New Insulin Assay

James Frederick, PA-C, MMSc avatar

by James Frederick, PA-C, MMSc |

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Ortho Clinical Diagnostics, a producer of in vitro diagnostics, has 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).

The insulin assay is part of a comprehensive diabetes menu offered by Ortho and will be utilized in diabetes and pre-diabetes testing. Additionally, the assay can be used to monitor a broad range of metabolic conditions such as Cushing’s disease, pancreatic tumors, liver disease, acromegaly, and familial glucose-galactose malabsorption.

Cushing’s disease in caused by an over-secretion of the adrenocorticotropic hormone (ACTH), which in turn leads to an excess of cortisol production by the adrenal glands. The disease is estimated to affect 10-15 million people every year. Patients with Cushing’s suffer from weight gain, high blood pressure, excess hair growth, fatigue, and impaired immunologic function.

If untreated, excessive cortisol can also cause an elevation of blood glucose levels and patients may develop glucose intolerance — a prediabetic condition that can progress to diabetes.

“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,” Robert Yates, Ortho’s chief operating officer, said in a press release. “Adding Insulin to Ortho’s VITROS menu demonstrates our continued momentum in product development.”

The assay is expected to be commercially available for use in the U.S. beginning this fall.

Ortho’s Vitros Integrated System brings together five proven technologies designed to remove sample analysis obstacles and reduce the reading time of each sample, while increasing its ability to provide meaningful results.

The system processes up to 50 samples at a time, and conducts both chemistry and immune analysis at the same time. Because the process is fully automated, the need for operator intervention, maintenance, calibration, and manual interpretation is dramatically reduced. As a result, few operating errors occur.