MASSDEVICE ON CALL — The FDA this week officially approved Swiss healthcare giant Roche‘s COBAS INTEGRA 800 Tina-quant HbA1cDx assay as a test for diabetes.
The test has been in use as a diagnostic tool off-label, but has been officially marketed only as a means of monitoring blood glucose control.
"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," Alberto Gutierrez of the FDA’s Office of In Vitro Diagnostics & Radiological Devices said in prepared remarks. "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."
The clearance was based in part on testing that showed a less than 6% difference in accuracy between Roche’s assay and the standard hemoglobin analysis testing currently in use. The A1c test measure the amount of hemoglobin A1c bound to glucose, which provides a 3-month average glucose level, according to the FDA notice.
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