FDA Allows Marketing of First ZnT8Ab Autoantibody Test to Help Dagnose Type 1 Diabetes

August 20, 2014

Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.

Type 1 diabetes is the most common type of diabetes diagnosed in children and adolescents, but in some instances it may also develop in adults. People with the disease produce little or no insulin because their immune system attacks and destroys the cells in the pancreas that produce insulin, a hormone that converts sugars (glucose) in food to the energy the bodyneeds. People with type 1 diabetes mustinject insulinto regulate their blood glucose because proper regulation is critical to lower their risk of long-term complications such as blindness, kidney failure and cardiovascular disease.

The immune system of many people with type 1 diabetes produces ZnT8Ab, but patients with other types of diabetes (type 2 and gestational) do not. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay detects the presence of the ZnT8 autoantibody in a patient’s blood.

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