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Abbott HbA1c Test FDA Cleared to Diagnose Diabetes

NEW YORK (360Dx) – Abbott said on Thursday that the US Food and Drug Administration has cleared the company's Afinion HbA1c Dx assay to help diagnose diabetes mellitus and assess a patient's risk of developing the disease.

The rapid point-of-care assay was cleared to run on Abbott's Afinion AS100 Analyzer.

According to Abbott, until now the only HbA1c assays that were FDA cleared for diagnosing diabetes and assessing the risk of developing the disease were tests that ran on central laboratory instruments. In analytical and clinical studies, the Afinion HbA1c Dx assay has demonstrated test results comparable to tests run on central lab platforms.

"With our new expanded test indication, patients at risk for diabetes can receive their assessment within minutes, allowing them to work with clinicians to customize a care plan during a single visit," Elizabeth Balthrop, divisional vice president of cardiometabolic and informatics at Abbott, said in a statement. "This is especially impactful for patients who can't easily access or make multiple appointments at labs and doctor's offices."

The clearance allows the test to be run in laboratories with CLIA certification to perform tests that are moderate complexity or higher, but does not extend to labs that can run only CLIA-waived tests, Abbott said.

The test will be available in the US in late 2018.

In 2005, the FDA cleared the Afinion HbA1c assay for use on the Afinion AS100 Analyzer to deliver rapid HbA1c results for patient management of diabetes at the point of care. The system was CLIA waived in 2006, enabling broader use in qualified healthcare settings, Abbott said.

The Afinion AS100 Analyzer is a rapid multiassay analyzer that provides near-patient testing of HbA1c and albumin-to-creatinine ratio at the point of care.