FDA Approves Blood Test to Aid Diagnosis of Type 1 Diabetes

Type 1 diabetes blood test detects unique autoantibody

(RxWiki News) While Type 1 and Type 2 diabetes share some traits, treatments for each condition differ greatly. For this reason, doctors need to know which type of diabetes their patients have. Doctors now have a new tool that can help determine whether a patient has Type 1 diabetes.

The US Food and Drug Administration (FDA) has allowed marketing of Kronus, the first zinc transporter 8 autoantibody (ZnT8Ab) test, which can help determine whether a person has Type 1 diabetes.

"If you suspect you have diabetes, tell your primary care physician."

"Early treatment of type 1 diabetes is important to prevent further deterioration of insulin producing cells," said 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, in a press release. "This test can help patients get a timely diagnosis and help start the right treatment sooner."

In Type 1 diabetes, the immune system mistakenly attacks the pancreas. As a consequence, the pancreas loses the ability to produce the hormone insulin, which means that more sugar stays in the blood.

In Type 2 diabetes, the body produces too little insulin or cannot use the hormone effectively, leading to higher blood sugar levels.

In both types, the risk of complications increases as blood sugar rises. Such complications may include blindness, kidney failure and heart disease.

Type 1 diabetes is most commonly diagnosed in children and teens, but adults can develop the condition as well. People with Type 1 diabetes must inject insulin to manage their blood sugar levels.

The immune system of many people with Type 1 diabetes produces ZnT8Ab. However, patients with Type 2 diabetes or gestational diabetes (diabetes during pregnancy) do not produce the autoantibody. The Kronus ZnT8Ab ELISA Assay can identify the ZnT8 autoantibody in a patient's blood.

The FDA approved this new test after it was studied in a clinical trial that included 569 blood samples. Of these samples, 323 came from people diagnosed with Type 1 diabetes and 246 came from those diagnosed with other forms of diabetes, autoimmune diseases or conditions.

The test detected the ZnT8 autoantibody in 65 percent of the samples that came from those diagnosed with Type 1 diabetes. The test incorrectly detected the autoantibody in less than 2 percent of the samples that came from people diagnosed with other diseases.

According to the FDA, a negative result (when the test does not detect the ZnT8 autoantibody) does not rule out the possibility that a person has Type 1 diabetes. The agency also warned that the Kronus test should not be used to monitor the stage of disease or to gauge a patient's response to treatment.

Review Date: 
August 21, 2014