Novel Autoantibody Test for Type 1 Diabetes Approved by FDA

The Food and Drug Administration (FDA) has granted marketing approval of the KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay, the first ZnT8Ab test to help determine if a person has type 1 diabetes. This test may help patients receive an earlier diagnosis and treatment for their disease when used in combination with other tests and clinical information.

The KRONUS Zinc Transporter 8 Autoantibody ELISA Assay detects the presence of ZnT8Ab in the patient's blood sample. ZnT8Ab is produced in the immune system of many patients with type 1 diabetes, but not in those with other types such as type 2 or gestational diabetes.

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The approval was based on results from a clinical study of 323 blood samples of patients with type 1 diabetes and 246 blood 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 diagnosed type 1 diabetes and incorrectly gave a positive result in <2% of the samples from patients diagnosed with other disease.

For more information visit FDA.gov.

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