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Update on albumin/creatinine ratio (ACR) CLIA-waived status

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.   

 

Following the review of the CLIA (Clinical Laboratory Improvement Amendments) waiver application, the FDA has outlined several observations and suggestions for consideration and Axis-Shield will resubmit its application as soon as the additional data requested by the FDA have been generated.

 

CLIA waiver status indicates that non-professional users are able to offer tests to patients in view of the simplicity of the procedure.  No similar assay to Axis-Shield’s Afinion ACR test has been granted CLIA-waived status and the management team at Axis-Shield has consistently guided that the outcome of the application was always uncertain. 

 

The Afinion ACR test is CE-marked and currently available in Europe and the rest of the world, and was launched in the US in February 2008.   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 Axis-Shield’s CLIA-waived Afinion HbA1c assay that is used for monitoring the effectiveness of diabetes control in primary healthcare.

 

Ian Gilham, CEO of Axis-Shield, commented: “Although we recognise that no other quantitative assay for ACR in diabetes has received CLIA-waived status, we believe the Afinion test for this parameter can meet the requirement for a degree of simplicity which will minimalise risk of error and we will continue to work towards demonstrating that CLIA-waived status is justified. The market for ACR testing in diabetes is relatively small compared to HbA1c monitoring of glucose control in such patients and whilst we are disappointed with the current outcome, we are pleased that our multi-assay Afinion system will continue to allow many US physicians to test ACR at the point-of-care, in the important and growing diabetes diagnostics market.”