The FDA has approved a new test for diabetes patients.
The test is the first zinc transporter 8 autoantibody test (ZnT8Ab) that can be used to determine whether a person has type 1 diabetes or another type of diabetes. This may help patients with type 1 diabetes be diagnosed quickly so they can begin treatment.
The test, which determines levels of the autoantibody produced by the diabetes patient, is produced by Kronus Market Development Associates.
"Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells," said 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 right treatment sooner."
Type 1 diabetes, also known as juvenile onset diabetes, is the most common form of diabetes in children. Occasionally, it may develop in adults, but only when the body produces little to no insulin as a result of its immune system attacking and destroying cells in the pancreas.
Insulin helps convert glucose sugar into food that fuels the body. If people lack the hormone, they have to inject insulin into their bodies to regulate the blood glucose. Untreated, this lack of insulin can cause complications such as blindness, kidney failure and heart disease.
Type 1 diabetes patients, unlike other patients, produce autoantibody ZnT8Ab.
The clinical trials used to approve the test involved 569 blood samples from 323 patients with type 1 diabetes and 246 patients with other kinds of diseases. The test was successful for detecting the autoantibody in 65 percent of samples.
The test involves using an enzyme-linked immunosorbent assay to detect the presence of ZnT8Ab in a patient's blood.
A negative result from the test does not rule out type 1 diabetes, but it gives a false positive result only 2 percent of the time.
The FDA also said the test should not be used as a way to monitor treatment.
The test was reviewed using the FDA's de novo premarket review regulatory pathway for low- to moderate-risk medical devices.
According to the CDC, 151,000 people below the age of 20 have type 1 diabetes.
