FDA Approves New Type 1 Diabetes Test

The US Food and Drug Administration recently announced the approval of the KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay, a new test for type 1 diabetes.

The test is the first of its kind to receive FDA approval and can differentiate type 1 diabetes from other forms of the disease, which could help more people get diagnosed and treated for the condition.

“When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease,” according to the FDA statement.

The KRONUS ZnT8Ab ELISA Assay tests for ZnT8 in patients. Only those patients with type 1 diabetes produce the autoantibody, which helps in patient diagnosis.

“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 Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health. “This test can help patients get a timely diagnosis and help start the right treatment sooner.”

According to the FDA, the test went through the de novo premarket review pathway, which it described as “a regulatory pathway for some low-to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.”

Testing included a total of 569 blood samples of which 323 came from patients previously diagnosed with type 1 diabetes. The remainder had either been diagnosed with either other forms of diabetes or other conditions. The results showed the test was able to detect the autoantibody in 65% of the samples from the type 1 patients and only gave a positive result in less than 2% of patients with other diseases.

The test is manufactured by KRONUS Market Development Associates, Inc. of Star, ID.