As the article states, current tests have been approved to only monitor glucose levels and now with this approved test there’s a somewhat one stop test to do it. A value of 6.5% will indicated the condition. The text is manufactured by Roche. BD
The FDA has approved the first glycated hemoglobin (HbA1c) test to diagnose diabetes, the agency announced Thursday.
The Cobas Integra 800 Tina-quant HbA1cDx assay, made by Roche, will be the first such test that FDA will allow to be marketed as a diagnostic tool. HbA1c tests currently on the market have been approved only to monitor blood glucose control, not to diagnose diabetes.