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news.The US Food and Drug Administration (FDA) has authorized the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that helps in determination of Type 1 Diabetes.
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Manufactured by Kronus Market Development Associates, ZnT8Ab test can help some type 1 diabetic patients receive timely diagnosis and treatment for their disease.
Characterized by failure of insulin production, Type 1 diabetes is the most common type of diabetes in children and adolescents, and may also develop in adults in some instances.
FDA Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health director Alberto Gutierrez 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."
ZnT8Ab ELISA Assay works by detecting the presence of the ZnT8 autoantibody that is produced by the immune system of many type 1 diabetic patients, in a patient’s blood.
The FDA reviewed the Assay 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.
During clinical trials, the test could detect the ZnT8 autoantibody in 65% of the 323 samples from patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than 2% of the 246 samples from patients diagnosed with other disease.
FDA notes that a negative ZnT8Ab ELISA Assay does not rule out a diagnosis of type 1 diabetes.