June 3, 2013

FDA Approves HbA11c Test for Diabetes Diagnosis


HbA1c-diagnosisFDA allows marketing of first HbA1c test labeled for diagnosing diabetes. The name of this first-ever diabetes diagnostic device is the COBAS INTEGRA 800 for healthcare professionals.

HbA1c tests measure the percentage of glucose in the blood over a 3-month period. Healthcare professionals use a combination of a glucose tolerance test, fasting blood test, and the HbA1c to diagnose diabetes.

Before the FDA approval of  the COBAS INTEGRA 800, HbA1c tests were not specifically marketed for diabetes diagnosis, making it difficult to know which A1c tests were accurate enough for this purpose. The Roche blood assay device is a laboratory-based test and can be used to both accurately diagnose diabetes and monitor blood glucose control.

The margin of err of the COBAS INTEGRA 800 is less than 6% difference, when testing 141 blood samples compared to the standard reference for hemoglobin analysis. The use of this medical device allows healthcare professionals a tool to more accurately, more effectively, and cost-efficiently manage their patients.

“Providing healthcare 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.

Thanks to the collaborative efforts of Roche, Microsoft, and the FDA, the real highlight of the COBAS INTEGRA 800 is that it may help identify people flirting with prediabetes and provoke preventative lifestyle changes before the other shoe drops and T2D is a permanent part of your daily grind.

Visit Your Diabetes Health for more resources about health.