The FDA today approved marketing of the Kronus Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay, the first ZnT8Ab test to differentiate type 1 diabetes from another type of diabetes in a patient, according to a press release.
ZnT8Ab is produced by the immune system of many people with type 1 diabetes, but this is not the case with type 2 diabetes or gestational diabetes. The Kronus Zinc Transporter 8 Autoantibody ELISA Assay detects ZnT8Ab in the blood.
The assay was reviewed through the de novo premarket review pathway, which is a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
The FDA based its decision on results from a clinical study showing that the Kronus assay could detect the ZnT8 autoantibody in 65% of samples from patients diagnosed with diagnosed type 1 diabetes. False positive results occurred in less than 2% of samples.
The clinical study included 569 samples, 323 from patients with diagnosed type 1 diabetes and 245 samples from those diagnosed with other types of diabetes, other autoimmune diseases or other clinical conditions, according to the release.
“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin-producing cells,” 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, said in the release.
“The test can help patients get a timely diagnosis and help start the treatment sooner.”
The assay should not be used to monitor disease stage or treatment response, according to the release.