INDIANAPOLIS, IN – For the first time, the U.S. Food and Drug Administration is allowing marketing of an HbA1c test specifically for diagnosing diabetes.
Approval was given for the Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay), manufactured by Roche, for the diagnosis of diabetes by healthcare professionals.
Other HbA1c tests on the market are FDA-cleared for monitoring a patient’s blood glucose control but not for diagnosing the disease.
While healthcare providers already have 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, those assays were not specifically designed for diabetes diagnosis, and their accuracy has not established for diagnosis purposes, according to the FDA.
“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,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Devices at FDA’s Center for Devices and Radiological Health.
In studies leading to the product’s approval, investigators analyzed 141 blood samples and found less than 6% difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared with results from the standard reference for hemoglobin analysis.
The FDA cautioned that hemoglobin A1c tests, including the Tina-quant HbA1cDx assay, should not be used to diagnose diabetes during pregnancy and should not be used to monitor diabetes in patients with hemoglobinopathy, hereditary spherocytosis, malignancies or severe chronic, hepatic and renal disease. The test also should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F.