Marketing of new diabetes test approved by US FDA

Written by Dominic Chamberlain, Future Science Group
Clinical News Regulated bioanalysis
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The US FDA has allowed KRONUS Market Development Associates, Inc. (ID, USA) to market the first zinc transporter 8 autoantibody (ZnT8Ab) test for Type 1 diabetes.

The US FDA has announced that it will allow the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test. The test can help determine if a person has Type 1 diabetes versus another type of diabetes. Type 1 diabetes is the most common type of diabetes diagnosed in children and adolescents, but can also develop in adults.

The test, when used alongside other tests and patient clinical information, may help some people with Type 1 diabetes receive timely diagnosis of, and treatment for, their disease. The Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay developed by KRONUS (ID, USA) works by detecting ZnT8Ab in the blood, which is produced by the immune system of people with Type 1 diabetes but not in patients with other types of diabetes (Type 2 and gestational).

Discussing the test, Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health at the FDA, commented, “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.”

The KRONUS ZnT8Ab ELISA Assay was reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

Before making its decision, the FDA reviewed 569 blood samples made up of samples from patients with diagnosed Type 1 diabetes and samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases and other clinical conditions. The test detected the ZnT8 autoantibody in 65% of the samples from patients with diagnosed Type 1 diabetes and gave an incorrect positive result in less than 2% of the samples from patients diagnosed with other diseases.

In their press release, the FDA stress that a negative result from the test does not rule out a diagnosis of Type 1 diabetes; therefore, the test should not be used to monitor the stage of disease or the response to treatment.

Source: FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes.