New diagnostic tool for type 1 diabetes gets US FDA clearance

A new test that can determine if a person has type 1 diabetes and not another type of diabetes has been given the green light in the USA.
The country’s Food and Drug Administration (FDA) has cleared the KRONUS Zinc Transporter 8 Autoantibody ELISA assay, a newly developed test distinguishes type 1 diabetes from other kinds of diabetes by detecting for the presence of the ZnT8 antibody in the blood. This antibody is produced by the immune system of many patients with type 1 diabetes, but not those with type 2 or gestational diabetes mellitus.
By improving the accuracy of type 1 diabetes diagnosis, it is hoped that cases of the disease will be identified and treated earlier, at a stage where some insulin producing function can be preserved.
“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” said Alberto Gutierrez, 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.”
The FDA’s marketing approval of the ZnT8Ab ELISA assay was based on analysis of a study of 569 blood samples: 323 from patients diagnosed with type 1 diabetes and 246 from those with other types of diabetes, other autoimmune diseases, and unrelated clinical conditions.
The first-of-its-kind test was able to detect the ZnT8 antibody in nearly two thirds (65%) of the type 1 samples, with positive results incorrectly given in less than 2% of the samples from patients with other diseases.
Manufacturer KRONUS is a US-based provider of autoimmune diagnostic test kits and reagents to the research and clinical laboratory marketplace.