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FDA Allows Marketing of First A1c Test Labeled for Diagnosing Diabetes

Today the U.S. Food and Drug Administration 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. This is the first HbA1c test that 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.

Diabetes is a serious, chronic metabolic condition where the body is unable to convert glucose into the energy needed to carry out daily activities. An estimated 25.8 million people in the United States have diabetes, including seven million people who remain undiagnosed. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys, and nerves.

The diagnostic criteria for diabetes have changed over time. 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 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.

"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, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Devices at 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."

In support of marketing clearance, investigators analyzed 141 blood samples and found less than six percent difference in the accuracy of test results from the Tina-quant HbA1cDx assay compared to results from the standard reference for hemoglobin analysis.

The Tina-quant HbA1cDX assay is available by prescription for use in clinical laboratories. Over-the-counter HbA1c tests should not be used by patients to diagnose diabetes, and only a qualified health care professional should make a diagnosis of diabetes.Individuals who receive a diabetes diagnosis should discuss with their physician what they need to do to manage their diabetes.

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. This test should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F.

The Tina-quant HbA1cDx assay is manufactured by Roche, of Basel, Switzerland. Roche's North American headquarters are located in Indianapolis, Ind.

SOURCE:

FDA

May 24, 2013



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