The FDA on Thursday granted marketing clearance for the first HbA1c test for diagnosing diabetes - COBAS INTEGRA 800 Tina-quant HbA1cDx assay, manufactured by Roche, of Basel, Switzerland.
The HbA1c test, also known as A1c test, shows a patient's average glucose level over a three-month period. The A1c tests currently on the market are FDA-cleared for monitoring a patient's blood glucose (sugar) control, but not for diagnosing diabetes.
Roche's Tina-quant HbA1cDx assay won the marketing clearance for diagnosing diabetes based on an analysis of 141 blood samples, which showed less than six percent difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared to results from the standard reference for hemoglobin analysis.
The FDA in a statement said that the Tina-quant HbA1cDX assay is available by prescription for use in clinical laboratories. Over-the-counter HbA1c tests should not be used by patients to diagnose diabetes, and only a qualified health care professional should make a diagnosis of diabetes.
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