FDA Approves First A1c Test to Diagnose Diabetes

Megan Brooks

Disclosures

May 23, 2013

It is official: Health professionals can use the Cobas Integra 800 Tina-quant HbA1cDx assay (Roche) to diagnose diabetes, the US Food and Drug Administration announced today.

It is the first HbA1c test that the agency has allowed to be marketed for diabetes diagnosis. The HbA1c tests currently on the market are FDA-cleared for monitoring blood glucose control but not for diagnosing diabetes.

"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," the FDA said in a news release. "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."

One More Tool

"Providing healthcare 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, 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," Dr. Gutierrez added.

In support of marketing clearance, investigators analyzed 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 hemoglobin analysis, the FDA said.

The assay is available by prescription for use in clinical laboratories.

The FDA said over-the-counter HbA1c tests should not be used by patients to diagnose diabetes, and only a qualified healthcare professional should make a diagnosis of diabetes.

The agency also noted that A1c tests, including the new 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 also should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F.

An estimated 25.8 million people in the United States have diabetes, including 7 million people who remain undiagnosed.

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