- September 19, 2019
The company describes the assay as the first and only rapid test cleared by the FDA for use in diagnosing diabetes or for monitoring a person’s risk for developing the condition in the future. The Afinion HbA1c Dx test is now available for use on Abbott’s Afinion 2 and AS100 analyzers.
“In addition to giving physicians the certainty of diagnosis they need to make informed decisions during a patient visit, the HbA1c Dx assay gives people living with diabetes near real-time results, so that in consultation with their doctor they can make adjustments to their lifestyle and better manage their condition,” Elizabeth Balthrop, Vice President of Cardiometabolic and Informatics in Abbott’s Rapid Diagnostics diagnostics, said in a statement.
The diagnostics assay first received FDA clearance on the AS100 analyzer in May 2018, around the same time as the launch of the Afinion 2 platform. The new test also complements the previous Afinion HbA1c assay, which was approved solely for monitoring long-term glycemic control at the point-of-care, the company said.
In June at the annual Scientific Sessions of the American Diabetes Association, Abbott presented its first evaluation of real-world data for its FreeStyle Libre continuous glucose monitoring system in people with Type 2 diabetes.
The data showed that the system could help reduce hemoglobin A1c levels by nearly a full percentage point after three (3) months of use among patients who had taken multiple insulin injections per day for several years.
REFERENCE: Fierce BioTech; 17 JUN 2019; Conor Hale