FDA Clears Blood Test to Help Diagnose Type 1 Diabetes

Megan Brooks

August 21, 2014

The US Food and Drug Administration (FDA) has approved the first zinc transporter 8 autoantibody test (ZnT8Ab, Kronus) that can help determine whether a person has type 1 diabetes and not another type of diabetes.

People with type 1 diabetes produce ZnT8Ab, while patients with type 2 and gestational diabetes do not. The ZnT8Ab enzyme-linked immunoassay (ELISA) detects the presence of the ZnT8 autoantibody in blood, the FDA said in a news release.

"Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin-producing cells," said Alberto Gutierrez, PhD, director of the FDA's Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health, said in the release. "This test can help patients get a timely diagnosis and help start the right treatment sooner."

The agency approved the test based on data from a clinical study of 569 blood samples: 323 from patients with type 1 diabetes and 246 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 FDA said.

"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," the agency said.

The ZnT8Ab ELISA was reviewed 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 said.


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