New diagnostic tool for type 1 diabetes gets US FDA clearance

Posted on August 20, 2014 by DiabetesDigest.com Staff in News

A new test that can determine if a person has type 1 diabetes and not another type of diabetes has been given the green light in the USA.
The country’s Food and Drug Administration (FDA) has cleared the KRONUS Zinc Transporter 8 Autoantibody ELISA assay, a newly developed test distinguishes type 1 diabetes from other kinds of diabetes by detecting for the presence of the ZnT8 antibody in the blood. This antibody is produced by the immune system of many patients with type 1 diabetes, but not those with type 2 or gestational diabetes mellitus.
By improving the accuracy of type 1 diabetes diagnosis, it is hoped that cases of the disease will be identified and treated earlier, at a stage where some insulin producing function can be preserved.
“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health at the FDA.
“This test can help patients get a timely diagnosis and help start the right treatment sooner.”
The FDA’s marketing approval of the ZnT8Ab ELISA assay was based on analysis of a …read more

Source:: News from Diabetes.co.uk

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