24 May 2013 - 24 May 2013 - US Food and Drug Administration (FDA) said Thursday it had authorised the marketing of Swiss Roche's (VTX:ROG) Cobas Integra 800 Tina-quant HbA1cDx assay to diagnose diabetes.

HbA1c tests, or A1c tests, are presently approved by the agency for monitoring a patient's blood glucose control but not for the diagnosis of diabetes. Such assays evaluate the percentage of hemoglobin A1c bound to glucose, giving a patient's average glucose level over three months.

The clearance for the Tina-quant HbA1cDx test was based on analyses of 141 blood samples, which showed less than 6% difference in the accuracy of the results from the test, compared with data from the standard reference for hemoglobin analysis.

The Tina-quant HbA1cDX test is available for laboratory use only.