New Test Helps Diagnose Type 1 Diabetes
But negative result doesn't rule out disease, FDA warns
By Scott Roberts
THURSDAY, Aug. 21, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new test that may help doctors diagnose type 1 diabetes, the most common form diagnosed in children and adolescents.
The Kronus ZnT8Ab Elisa Assay may help some people with type 1 diabetes receive faster diagnosis and treatment, the FDA said in a news release. People with type 1 diabetes produce little or no insulin because cells in the pancreas that produce the hormone are mistakenly attacked by the body's immune system.
Insulin is a hormone that converts sugars (glucose) in food to fuel for the body. People who lack the hormone must inject insulin to regulate blood glucose and lower their risk of potential complications, including blindness, kidney failure and heart disease.
The test was able to diagnose a key marker in 65 percent of samples from people diagnosed with type 1 diabetes, and incorrectly gave a positive result in less than 2 percent of samples, the FDA said.
On the other hand, the agency stressed that negative test result should not rule out a diagnosis of type 1 diabetes. The test also shouldn't be used to monitor the body's response to treatment, the FDA added.
The new test is produced by Kronus Market Development Associates, based in Star, Idaho.