FDA OKs Abbott’s Point-of-Care Diabetes Diagnostic Test

Abbott 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.¹
 
“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.
 
Reference
¹ 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.