FDA Approves Blood Test to Diagnose Diabetes


WASHINGTON, May 23, 2013  (AP) — The Food and Drug Administration said Thursday it approved a new from Roche to help doctors .

The Cobas Integra 800 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.

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 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.


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