FDA Approves Marketing of First ZnT8Ab Autoantibody Assay for Type 1 Diabetes Diagnosis

The U.S. Food and Drug Administration (FDA) approved for marketing the first zinc transporter 8 autoantibody (ZnT8Ab) test to aid in the diagnosis of type 1 diabetes.Type 1 Diabetes being handwritten in red on screenThe test—known as the Kronus ZnT8Ab ELISA Assay—measures autoantibodies to the insulin secretory granule zinc transporter (ZnT8), the product of the SLC30A8 gene. For many people with type 1 diabetes, the immune system makes ZnT8Ab; in contrast, patients with other types of diabetes (eg, type 2 and gestational) do not make these antibodies.

“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 a clinical study, the test was able to detect the ZnT8 autoantibody in 65% of the 323 blood samples from patients with diagnosed type 1 diabetes, and incorrectly gave a positive result in less than 2% of the samples from patients diagnosed with other types of diabetes, other autoimmune disease, and other conditions. 

The FDA noted that a negative test result from the assay does not rule out the diagnosis of type 1 diabetes, and that the test should be used along with other tests and patient clinical information when making a diagnosis.

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