New Assay Helps Diagnose Type 1 Diabetes
But negative result doesn't rule out disease, FDA warns.
The U.S. Food and Drug Administration has approved a new test that may help doctors diagnose type 1 diabetes. The Kronus ZnT8Ab Elisa Assay may help some people with type 1 diabetes receive faster diagnosis and treatment, the FDA said in a news release.
Data were examined from a clinical study of 569 blood samples -- 323 from patients with diagnosed type 1 diabetes and 246 from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions. The test was able to diagnose a key marker in 65 percent of samples from people diagnosed with type 1 diabetes, and incorrectly gave a positive result in less than 2 percent of samples, the FDA said.
However, the FDA stressed that a negative test result should not rule out a diagnosis of type 1 diabetes. In addition, the test also shouldn't be used to monitor the body's response to treatment.
"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 new test is produced by Kronus Market Development Associates, based in Star, Idaho.