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FDA Approves First ZnT8Ab Autoantibody Test to Help Diagnose Type-1 Diabetes

Assay detects antibody in 65% of blood samples

The FDA has allowed marketing of the Kronus zinc transporter 8 autoantibody (ZnT8Ab) ELISA assay — the first ZnT8Ab test to help determine whether a person has type-1 diabetes and not another form of diabetes.

According to the tests’ developer (Kronus Market Development Associates, Inc.), when used with other tests and patient clinical information, the ZnT8Ab assay may help some people with type-1 diabetes receive timely diagnosis and treatment for their disease.

Type-1 diabetes is the most common form of diabetes diagnosed in children and adolescents, but in some cases it can also develop in adults. People with the disease have little or no insulin because their immune system attacks and destroys insulin-producing cells in the pancreas.

The immune system of many people with type-1 diabetes produces ZnT8Ab, but patients with other forms of diabetes (i.e., type-2 and gestational) do not. The Kronus assay detects the presence of the ZnT8 autoantibody in a patient’s blood.

“Early treatment of type-1 diabetes is important in helping to prevent further deterioration of insulin-producing cells,” said Alberto Gutierrez, PhD, 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.”

In reaching its decision, the FDA reviewed data from a study of 569 blood samples — 323 samples from patients diagnosed with type-1 diabetes, and 246 samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions. The Kronus assay was able to detect ZnT8Ab in 65% of the samples from patients with type-1 diabetes and incorrectly gave a positive result in less than 2% of the samples from patients with other diseases.

Source: FDA; August 20, 2014.

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