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FDA OKs Afinion HbA1c Dx to diagnose diabetes

June 26, 2018Abbott announced the FDA has cleared the Afinion HbA1c Dx assay, a rapid point-of-care test to help diagnose diabetes mellitus and assess a patient’s risk of developing the disease, for use with the Afinion AS100 Analyzer. In analytical and clinical studies, the Afinion HbA1c assay demonstrated accurate, precise, and reliable results comparable with those of central laboratory systems (Swensen MH, et al. Poster presented at American Diabetes Association 76th Scientific Sessions; June 10–14, 2016; New Orleans, La.).

“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,” Elizabeth Balthrop, divisional vice president of cardiometabolic and informatics at Abbott, said in a press release.

The test will be available in the United States in late 2018. It is approved for use in settings with CLIA certification to perform tests that are moderate complexity or higher.

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