Axis-Shield receives United States FDA 510(K) Clearance for Afinion Albumin/Creatinine Ratio Test

Axis-Shield, the international in-vitro diagnostics company, today announces that it has received Food and Drug Administration (FDA) 510(k) marketing clearance for its Albumin/Creatinine Ratio (ACR) test on the award-winning point-of-care Afinion™ system.

The Afinion™ ACR test is CE-marked and currently available in Europe and the rest of the world, and will now be launched in the USA. The assay measures the ACR in urine and is a measure of kidney function and cardiovascular complications that may occur in people with poorly controlled diabetes. It complements the CLIA-waived Afinion™ HbA1c assay used for monitoring diabetes treatment in primary healthcare. According to the American Diabetes Association (ADA), there are nearly 21 million people with diabetes in the United States. The ADA recommends HbA1c testing for all people with diabetes between 2-4 times per year. In addition, the ADA, the National Institute of Health and the National Kidney Foundation all recommend annual testing for microalbuminuria (albumin in urine) in people with diabetes, as an early indicator of kidney failure, which is the cause of death in up to 20% of people with diabetes.

Ian Gilham, Axis-Shield CEO, commented: “We are pleased to have achieved FDA 510(k) clearance for the Afinion™ ACR test. Our multi-assay Afinion™ system now allows physicians to test both HbA1c and ACR at the point-of-care, both well recognised as important elements of the overall management of diabetes. We look forward to the successful market introduction of the new Afinion™ ACR test in the US market through our partners, Abbott Laboratories.”