New Blood Test Approved to Diagnose Type 1 Diabetes

The FDA has allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test which can help determine whether a person has type 1 diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive a timely diagnosis and treatment for their disease. 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 agency reviewed data from a clinical study of 569 blood samples — 323 from patients with diagnosed type 1 diabetes and 246 samples 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 diseases. The assay is manufactured by KRONUS Market Development Associates, Inc. in Star, Idaho.