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FDA Approves Roche (RHHBY)'s Blood Test to Diagnose Diabetes


5/24/2013 8:19:49 AM

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The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. 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.

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