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news.Axis-Shield has received FDA marketing clearance for its novel HbA1c test, formulated to run on the widely placed, high-throughput AxSYM laboratory analyser from Abbott.
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The test, which is used to monitor treatment efficacy in patients with diabetes, will now be launched into the US marketplace. Assay development involved novel Axis-Shield patented technology from pioneering research at its Dundee plant, which has allowed measurement of this important marker on an automated high throughput immunoassay system. The assay is the fourth to have been launched under the AxSYM xtra program, whereby Axis-Shield produces tests under its own branding to run on this popular system.
Ian Gilham, CEO of Axis-Shield, said: “The American Diabetes Association recommends HbA1c testing two to four times per year for all people with diabetes. We are now able to offer the test in the laboratory on AxSYM as well as in the doctor’s office on our Afinion point-of-care analyser and on the long-established NycoCard system.”