Correction: Diabetes Test-FDA story
WASHINGTON (AP) — In a story May 23 about the approval of a Roche diagnostic tool for diabetes, The Associated Press misidentified the blood test as the Cobas Integra 800. The story should have described the product as the HbA1cDx, Gen 2 test, which runs on the Cobas Integra 800 system.
A corrected version of the story is below:
FDA approves blood test to diagnose diabetes
Roche blood test is first to win FDA approval for diabetes diagnosis
WASHINGTON (AP) — The Food and Drug Administration said Thursday that it approved a Roche blood test to help doctors diagnose diabetes.
The company's HbA1cDx, Gen 2 product is a blood test that measures a patient's average blood sugar level over the previous three months. In particular, the test measures an oxygen-carrying blood component known as hemoglobin. The test runs on the Cobas Integra 800 clinical chemistry analyzer.
Such tests have long been used to monitor blood sugar levels in people with diabetes. The FDA said Roche's test is the first to be approved to help diagnose the disease.
"Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appropriate guidance on treatment before problems develop," said Alberto Gutierrez, FDA's director of in vitro diagnostic tests.
More than 25 million people in the U.S. are estimated to have diabetes. People with type 2 diabetes are unable to properly break down carbohydrates, either because their bodies do not produce enough insulin or because they've become resistant to the hormone, which controls blood sugar levels. These patients are at higher risk for heart attacks, kidney problems, blindness and other serious complications.