FDA Clears First Point-of-Care Test to Diagnose Diabetes

Megan Brooks


June 21, 2018

The US Food and Drug Administration (FDA) has approved the Afinion HbA1c Dx assay (Abbott), the first rapid point-of-care test to diagnose diabetes and assess a patient's risk of developing the disease, the company announced.

The Afinion HbA1c Dx assay is for use with the Afinion AS100 Analyzer.

Until now, the only hemoglobin A1c (HbA1c) assays cleared for diagnosing diabetes and assessing the risk of developing diabetes were those that run on central laboratory instruments, the company explained in a news release. In analytic and clinical studies, the Afinion HbA1c Dx assay showed accurate, precise, reliable results that were comparable to those of central laboratory systems, the company said.

"Millions of people are either at risk for diabetes or unaware that they already have the condition," Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Abbott, said in the release.

"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. This is especially impactful for patients who can't easily access or make multiple appointments at labs and doctor's offices," said Balthrop.

The Afinion HbA1c assay, for use with the Afinion AS100 Analyzer, was cleared in 2005 for rapid delivery of HbA1c results for the point-of-care management of patients with diabetes. The FDA granted Clinical Laboratory Improvement Amendments (CLIA) waiver for the system in 2006, enabling broader use in qualified healthcare settings.

The new clearance for the expanded diagnostic indication is specific to laboratories with CLIA certification to perform tests that are of moderate or higher complexity and does not extend to those that can only perform CLIA-waived tests, the company said.

The test will be available in the United States in late 2018.

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