The Food and Drug Administration will now allow the KRONUS Zinc Transporter 8 Autoantibody ELISA Assay test to help determine whether a person has type 1 diabetes and not another form of the disease, to be marketed in the US. The test detects the presence of the ZnT8 autoantibody in a patient’s blood. While the immune system of many type 1 diabetics produces ZnT8Ab, those with type 2 and gestational diabetes do not. The test detects the presence of the ZnT8 autoantibody in a patient’s blood. 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.
“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” stressed 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.”
Type 1 diabetes, there are cases in which it may also develop in adults. Those with the disease produce little or no insulin because their immune system attacks and destroys the cells in the pancreas that produce insulin, which converts glucose (sugars) in food to the energy the body needs. To compensate, people with type 1 diabetes must inject themselves with insulin to regulate their blood glucose in order to reduce their risk of long-term complications such as blindness, kidney failure and cardiovascular disease.
In making its decision, the FDA examined data from a clinical study of 569 blood samples, 323 of which were provided by patients with diagnosed type 1 diabetes and 246 samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions. The test was able to detect the ZnT8 autoantibody in 65 percent of the samples from patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than 2% of the samples from patients diagnosed with other disease. However, they warned that a negative result from the test does not necessarily “rule out a diagnosis of type 1 diabetes.” In addition, it was stated that the KRONUS test “should not be used to monitor the stage of disease or the response to treatment.”