Roche HbA1c test approved for diagnosing diabetes in the US

Healthcare professionals in the United States can now use the COBAS INTEGRA 800 Tina-quant HbA1cDx test to diagnose patients with diabetes .
The US Food and Drug Administration (FDA) announced today that they will allow the marketing of the Roche-produced test for diagnosing cases of diabetes and monitoring diabetes control in clinical laboratories.
In a press release, the health regulator said investigators analysed 141 blood samples and found less than 6% difference in the accuracy of test results from the new assay compared with results from the standard reference for HbA1c analysis.
“Before today, A1c tests were not specifically designed or granted permission by 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 .”
Alberto Gutierrez, of the FDA’s Center for Devices and Radiological Health, said: “Providing healthcare professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appropriate guidance on treatment before problems develop.
“As the Tina-quant HbA1cDx assay was designed for diabetes diagnosis and has been reviewed by the FDA, physicians can have confidence that this test is reasonably safe and effective when used for its intended purposes of monitoring and diagnosing diabetes.”