Diagnostics manufacturer Abbott recently announced FDA clearance of the Afinion HbA1c Dx assay for use with the Afinion™ AS100 Analyzer. The assay is the first-ever rapid point-of-care test approved to help diagnose diabetes and assess patients’ risk of developing the disease by offering precise and reliable results comparable to those of central laboratory systems
Editor's Note: This article originally shared by an Abbott representative.
THE FIRST-EVER POINT-OF-CARE HbA1c ASSAY CLEARED FOR DIAGNOSING DIABETES AND IDENTIFYING PATIENTS AT RISK FOR DIABETES
Abbott Park, Ill., June 21, 2018 – Abbott today announced that the U.S. Food and Drug Administration (FDA) has cleared the Afinion HbA1c Dx assay for use with the Afinion™ AS100 Analyzer, the first-ever rapid point-of-care test to help diagnose diabetes mellitus and assess patients' risk of developing the disease.
Until now, the only HbA1c assays cleared for diagnosing diabetes and assessing the risk of developing diabetes were those that run on central laboratory instruments. In analytical and clinical studies, the Afinion HbA1c Dx assay demonstrated accurate, precise and reliable results comparable to those of central laboratory systems.[i]
"Millions of people are either at risk for diabetes or unaware that they already have the condition," said Elizabeth Balthrop, divisional vice president, Cardiometabolic and Informatics, Abbott. "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."
"Diabetes is a serious chronic condition, but it can be successfully managed if patients are diagnosed early, treated appropriately and educated about healthy lifestyle changes," said Richard Kahn, Ph.D., former Chief Scientific and Medical Officer of the American Diabetes Association. "Access to rapid results at the point of care expedites diagnosis and allows providers to initiate immediate follow up and, ultimately, help their patients take control of their health."
The Afinion HbA1c assay on the Afinion AS100 Analyzer was previously cleared in 2005 for rapid delivery of hemoglobin A1c (HbA1c) results for patient management of diabetes at the point of care. The FDA granted CLIA (Clinical Laboratory Improvements Amendments) waiver for the system in 2006, enabling broader use in qualified healthcare settings. The recent clearance for the expanded diagnostic indication is specific to laboratories with CLIA certification to perform tests that are moderate complexity or higher and does not extend to those that can only perform CLIA waived tests.
The Afinion HbA1c Dx test will be available in the U.S. in late 2018.
About Afinion AS100 Analyzer
The Afinion AS100 Analyzer is a compact rapid, multi-assay analyzer that provides valuable near-patient testing of HbA1c and albumin to creatinine ratio (ACR) at the point of care. The platform utilizes the latest technology and provides a simple, fast and reliable method by which to diagnose diabetes and monitor patients' disease progression.
About Diabetes
According to the U.S. Centers for Disease Control and Prevention, the United States has one of the highest prevalence rates for diabetes.[ii] More than 30 million people (or 9.4 percent of the population) have diabetes, a chronic metabolic condition that occurs when the body cannot use insulin efficiently, causing sugar (glucose) to build up in the bloodstream.3
Diabetes can cause serious consequences, including problems with blood vessels, heart, nerves, kidneys, mouth, eyes and feet.2
About Abbott
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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[i] Swensen MH, et al. Evaluation of the Alere Afinion HbA1c Dx Test: Can Point of Care HbA1c Testing Deliver the Performance Needed for Diagnostic Use? American Diabetes Association's 76th Scientific Sessions; June 10-14, 2016; New Orleans, LA.
[ii] Centers for Disease Control and Prevention (CDC). New CDC report: More than 100 million Americans have diabetes or prediabetes. Available at https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html.
3 CDC. National Diabetes Statistics Report, 2017. Estimates of Diabetes and Its Burden in the United States. Available at https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
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