Blood Test to Detect Type 1 Diabetes Cleared by FDA

The FDA has approved the first zinc transporter 8 autoantibody (ZnT8Ab) test that may help patients with type 1 diabetes mellitus (T1DM) receive more timely diagnosis and treatment for the disease.

According to the FDA, many T1DM patients produce ZnT8Ab, but those with other types of diabetes do not. To help determine whether a patient has T1DM, rather than type 2 diabetes or gestational diabetes, the ZnT8Ab enzyme-linked immunoassay (ELISA) developed by KRONUS Market Development Associates, Inc, detects the presence of the ZnT8Ab autoantibody in a patient’s blood.

“Early treatment of T1DM 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 at the FDA. “This test can help patients get a timely diagnosis and help start the right treatment sooner.”

The FDA’s approval of the ZnT8Ab test was based on data from a clinical study of 323 blood samples taken from patients diagnosed with T1DM and 246 samples taken from patients diagnosed with other kinds of diabetes, autoimmune diseases, and clinical conditions. The results of the study showed the test was able to detect the autoantibody in 65% of blood samples from T1DM patients and incorrectly gave a positive result in <2% of samples from those diagnosed with another disease.

The FDA cautioned that a negative test result does not rule out a T1DM diagnosis. Consequently, the ZnT8Ab test should not be used to monitor a patient’s disease stage or response to treatment.