FDA allows marketing of first A1c test labeled for diagnosing diabetes

May 30, 2013

The U.S. Food and Drug Administration (FDA) has announced it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay for diagnosis of diabetes. This is the first HbA1c test the FDA has allowed to be marketed for that use. The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient’s blood glucose control, but not for diagnosing diabetes. A1c tests measure the percentage of hemoglobin A1c that is bound to glucose, giving a patient’s average glucose level over a three-month period. The Tina-quant HbA1cDx assay is manufactured by Roche.

The diagnostic criteria for diabetes have changed over time. Based on the research and recommendations of international diabetes experts, many healthcare providers have already been using some A1c tests to diagnose diabetes, in addition to the established diagnostic procedures of a fasting blood glucose test and an oral glucose tolerance test. However, before now, A1c tests had not been specifically designed or granted permission by the FDA to be marketed for diabetes diagnosis. The Tina-quant HbA1cDx assay, a laboratory-based test, can be used to both accurately diagnose diabetes and monitor blood glucose control.

In support of marketing clearance, investigators analyzed 141 blood samples and found less than 6% difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared to results from the standard reference for hemoglobin analysis. The assay is available by prescription for use in clinical laboratories. Hemoglobin A1c tests, including the Tina-quant HbA1cDx assay, should not be used to diagnose diabetes during pregnancy or in patients with the hemoglobin variant hemoglobin F. Learn more from the FDA press release.