FDA allows marketing of first A1c test labeled for diagnosing diabetes, from Roche

The US Food and Drug Administration yesterday (May 23) announced that it is allowing marketing of the Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals, a product from Swiss drug major Roche (ROG: SIX). This is the first HbA1c test that the FDA has allowed to be marketed for this use.

The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient’s blood glucose (sugar) 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 diagnostic criteria for diabetes have changed over time, said the FDA. Based on the research and recommendations of international diabetes experts, many health care 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 to diagnose diabetes. However, before today, A1c tests were not specifically designed or granted permission by the FDA to be marketed for diabetes diagnosis, making it difficult to know which A1c tests were accurate enough for this purpose. The Tina-quant HbA1cDx assay, a laboratory-based test, can be used to both accurately diagnose diabetes and monitor blood glucose control.