FDA Approves Test for Type 1 Diabetes

FDA www.fda.gov now allows the marketing of the first “Zinc Transporter 8 Autoantibody” (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease. However, a negative result from the test does not rule out a diagnosis of type 1 diabetes.

The immune system of many people with type 1 diabetes produces ZnT8Ab, but patients with other types of diabetes do not. The KRONUS ZnT8Ab ELISA Assay detects the presence of the ZnT8Ab in a patient’s blood.

“Early treatment for Type 1 diabetes 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 within the Center for Devices and Radiological Health at FDA. “This test can help patients get a timely diagnosis and help start the right treatment sooner.”

The KRONUS ZnT8Ab ELISA Assay was reviewed through the de-novo premarket review pathway, a regulatory pathway for some low to moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

KRONUS ZnT8Ab ELISA Assay is manufactured by KRONUS Market Development Associates, Inc. www.kronus.com in Star Idaho.