TIDMASD

RNS Number : 3265Y

Axis-Shield PLC

21 December 2010

AXIS-SHIELD PLC

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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) system will continue to allow many US physicians to test ACR at the point-of-care, in the important and growing diabetes diagnostics market."

For more information, please contact

 
 Axis-Shield plc 
 Ian Gilham, Chief Executive Officer   Tel: +44 203 178 7849 
  Ronny Hermansen, Finance Director 
 
 M:Communications 
 Mary-Jane Elliott / Emma Thompson     Tel: +44 207 920 2330 
  / Nick Francis                        E-mail: axisshield@mcomgroup.com 
 Geelmuyden Kiese (Norway) 
 Hakon Ronning                         Tel: +47 48 18 88 00

Notes for Editors:

About Axis-Shield

Axis-Shield is an international and innovative in vitro diagnostics company, headquartered in Dundee with R&D and manufacturing bases in Dundee and Oslo. The Group specialises in the supply of instruments and tests for the rapidly growing physician's office testing market and the development, manufacture and marketing of innovative proprietary diagnostics kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, sepsis and diabetes.

For more information on Axis-Shield, please refer to www.axis-shield.com

This information is provided by RNS

The company news service from the London Stock Exchange

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