Dundee, Scotland, 21 December 2010: Axis-Shield (LSE:ASD, OSE:ASD), the innovative international in vitro diagnostics company, today announces that, following an application originally filed in February 2009, the US Food and Drug Administration (FDA) has indicated that Axis-Shield’s application for CLIA-waived status on the Afinion Albumin/Creatinine Ratio (ACR) has been denied, although the test is cleared under the US FDA’s 510(k) procedure and currently marketed to US customers having CLIA-accredited facilities. This will have no material impact on Axis-Shield’s forecasted sales and following this outcome Axis-Shield will continue to market the ACR test on Afinion in the USA.