FDA Approves Test to Detect Type 1 Diabetes

The FDA has approved the first zinc transporter 8 autoantibody (ZnT8Ab) test that, when used in conjunction with other clinical tests, can help diagnose type 1 diabetes. 

The Kronus ZnT8Ab Elisa Assay test uses the patient’s blood to detect ZnT8Ab—an antibody produced primarily in the immune systems of individuals with type 1 diabetes.
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The efficacy of the test was reviewed in a clinical study of 569 blood samples—323 from individuals with type 1 diabetes and 246 from those with type 2 diabetes, autoimmune diseases, or other conditions.

ZnT8Ab was successfully detected in 65% of samples from patients diagnosed with type 1 diabetes, and incorrectly detected in less than 2% of those without the condition.

“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” researchers wrote. “This test can help patients get a timely diagnosis and help start the right treatment sooner.”

—Michael Potts

FDA. FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes [press release]. 2014 August 20. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410830.htm. Accessed August 22, 2014.