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Type 1 Diabetes Diagnostic Test Allowed by the FDA
- Updated: August 25, 2014
The Food and Drug Administration (FDA) announced that marketing of the first ZnT8Ab autoantibody test used as an aid in diagnosing Type 1 Diabetes has been approved. Also referred to as a “zinc transporter 8 autoantibody”, this test is used in conjunction with other testing, as well as clinical information, as a diagnostic test specific only to Type 1 Diabetes.
Of the different types of Diabetes, Type 1 is the most common, something commonly diagnosed in children and teenagers although it can develop in adults in more rare instances. With this disease, the body is incapable of producing enough insulin or no insulin at all due to the immune system destroying pancreatic cells. These cells are needed for the production of insulin, which convers sugars into food, thereby providing the body with energy.
With the presence of Type 1 Diabetes, insulin needs to be injected in order for blood glucose to be regulated. Insulin injections prevent or dramatically lower long-term health risks to include kidney failure, blindness, and even cardiovascular disease. For many people with Type 1 Diabetes, the immune system produces ZnT8Ab whereas for those with Type 2 and Gestational Diabetes, it does not.
Using the new zinc transporter 8 autoantibody along with other testing, the presence of ZnT8Ab in the blood can be detected. According to 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, “This test can help patients get a timely diagnosis and help start the treatment sooner”.
Manufactured by KRONUS, this new test went through a premarketing review, which is used to regulate some low to moderate risk medical devices not yet deemed “substantially equivalent” to an existing legally marketed device. To determine its effectiveness and safety, data from blood samples taken from 569 participants in a clinical study were examined.
Of those samples, 323 came from people with Type 1 Diabetes while the remaining came from people with another form of the disease, some other type of autoimmune disease, or a variety of additional clinical conditions.
From the study, it was determined that ZnT8Ab was able to detect Type 1 Diabetes in 65% of the samples while it gave a positive result in less than 2% for people diagnosed with one of the other diseases. Although a negative result does not automatically mean a person does not have Type 1 Diabetes, it does help to monitor which stage the disease is in, as well as any response to treatment.