FDA Permits Marketing of Diabetes Diagnosis Test

The US Food and Drug Administration has announced that it will allow the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine whether or not a person has type 1 diabetes and not another type of the disease. The FDA believes that when used with other tests, as well as information obtained during a clinical exam, the test can help some people with type 1 diabetes receive timely diagnosis and treatment.

The immune systems of many people with type 1 diabetes produce ZnT8Ab, but patients with other types of diabetes (type 2 and gestational) do not. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay detects the presence of the ZnT8 autoantibody in a patient’s blood.

“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” said Alberto Gutierrez, Ph.D., 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 KRONUS ZnT8Ab ELISA Assay 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.

According to data from a clinical study of 569 blood samples, the test was able to detect the ZnT8 autoantibody in 65 percent of the samples from patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than two percent of the samples from patients diagnosed with other disease.

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.

Photo: Biz Life, Wikipedia

In type 1 diabetes the immune system produces ZnT8Ab which this test can identify.