The first zinc transporter 8 autoantibody (ZnT8Ab) test has been approved for marketing and the test can help determine if a person has diabetes mellitus type 1 and not another type of diabetes.

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 and people with the disease produce little or no insulin because their immune system attacks and destroys the cells in the pancreas that produce insulin.

The Food and Drug Administration (FDA; Silver Spring, MD, USA) has allowed marketing by review through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

The FDA reviewed data from a clinical study of 569 blood samples, 323 from patients with diagnosed type 1 diabetes and 246 samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions. The test was able to detect the ZnT8 autoantibody in 65% of the 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 disease. The Zinc Transporter 8 Autoantibody (ZnT8Ab) enzyme-linked immunosorbent assay (ELISA) Assay is manufactured by KRONUS Inc. (Star, ID, USA).

Alberto Gutierrez, PhD, the director of the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health at the FDA, said, “Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells. This test can help patients get a timely diagnosis and help start the right treatment sooner." A negative result from the test does not rule out a diagnosis of type 1 diabetes. The test should not be used to monitor the stage of disease or the response to treatment.

Related Links:
US Food and Drug Administration 
KRONUS Inc.