First-Ever Diagnostic Test for T1DM Receives FDA Approval

The test, the first-ever to distinguish the type 1 form of diabetes, could detect the ZnT8 autoantibody in 65 percent of the samples from patients with diagnosed type 1 diabetes and gave false positive results in less than two percent of the samples from patients diagnosed with other disease.

Today, the U.S. Food and Drug Administration allowed 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.

Type 1 diabetes is the most common type of diabetes diagnosed in children and adolescents, but in some instances it may also develop in adults. People with the disease produce little or no insulin because their immune system attacks and destroys the cells in the pancreas that produce insulin, a hormone that converts sugars (glucose) in food to the energy the body needs. People with type 1 diabetes must inject insulin to regulate their blood glucose because proper regulation is critical to lower their risk of long-term complications such as blindness, kidney failure and cardiovascular disease.

Read the press release here:

Source: US FDA