|The FDA has approved the first glycated hemoglobin (HbA1c) test to diagnose diabetes, the agency announced.
The Cobas Integra 800 Tina-quant HbA1cDx made by Roche will be the first such test that FDA will allow to be marketed as a diagnostic tool. HbA1c tests currently on the market have been approved only to monitor blood glucose control, not to diagnose diabetes.
The American Diabetes Association recommended using HbA1c to diagnose diabetes several years ago, with a value of 6.5% or higher indicating the condition. However, controversy has swirled over whether or not to diagnose the disease this way, as some researchers have cautioned that using this cutoff could miss too many cases of the disease.
"Providing health care professionals with another tool to identify undiagnosed cases of diabetes should help them provide patients appropriate guidance on treatment before problems develop," said Alberto Gutierrez, PhD, of FDA's Center for Devices and Radiological Health.
"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," Gutierrez added.
|Approval of the device to diagnose diabetes was based on an FDA investigation of 141 blood samples that revealed 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 agency said.
It cautioned, however, that the test should not be used to diagnose diabetes during pregnancy or to monitor diabetes in patients with hemoglobinopathy, hereditary spherocytosis, malignancies, or severe chronic, hepatic, or renal disease.
|Nor should the test be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F, the FDA said.