FDA OKs First ZnT8Ab Assay For Diagnosis Of Type 1 Diabetes

The U.S. Food and Drug Administration (FDA) has authorized the marketing of KRONUS Market Development Associates’ Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay for the early diagnosis of Type 1 diabetes.

The ZnT8Ab ELISA assay is designed to measure autoantibodies to the insulin secretory granule zinc transporter (ZnT-8), the product of the SLC30A8 gene in humans. The test kit is used to help determine whether a person has Type 1 diabetes and not another type of the disease. Used in conjunction with other clinical tests and patient clinical information, the assay may help T1D patients receive timely diagnosis and required treatment for their disease.

“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells. This test can help patients get a timely diagnosis and help start the right treatment sooner,” said Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health at the FDA.

Type 1 diabetes is the leading type of diabetes diagnosed in pediatric and adolescent patients, though it may also develop in adult patients. T1D is characterized by the inadequate or lack of production of the hormone insulin. The immune system attacks and kills the insulin-destroying cells in the pancreas of patients with T1D. These patients’ immune system produces the autoantibody ZnT8Ab, a characteristic that people with other types of diabetes do not possess. The ZnT8Ab ELISA assay detects the presence of the autoantibody in the patients’ blood.

The approval was supported by positive clinical study results that involved 560 blood samples. In the study, the assay was able to detect ZnT8Ab in 65 percent of patients with diagnosed T1D and erred in less than two percent of samples from patients with other types of diabetes.

The FDA cautioned that a negative result from the test does not mean a diagnosis of Type 1 diabetes is incorrect. The assay is not intended for monitoring the disease or a patient’s response to treatments.