FDA approves Tina-quant HbA1cDx assay (Roche) to diagnose Diabetes
The FDA has approved the marketing of the Cobas Integra 800 Tina-quant HbA1cDx assay, from Roche, for the diagnosis of Diabetes. This is the first HbA1c test that the FDA has allowed to be marketed for this use.
The assay, a laboratory-based test, can be used to both accurately diagnose Diabetes and monitor blood glucose control. In support of the marketing request, researchers 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 haemoglobin analysis.
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