AXIS-SHIELD PLC RECEIVES FDA CLIA WAIVER FOR AFINION™ SYSTEM WITH HbA1c TEST

Axis-Shield (LSE:ASD, OSE:ASD), the international in vitro diagnostics company, today announces that it has received Clinical Laboratory Improvement Amendments (CLIA) waiver for the AFINION™ point-of-care system with the HbA1c test (for monitoring diabetes treatment effectiveness) from the U.S. Food and Drug Administration (FDA).

CLIA waiver permits use of the test and system by non-professional staff in settings with reduced regulatory constraints, acknowledging that waived tests are easy to use, accurate, reliable and very unlikely to produce false results.

The AFINIONTM point-of-care system is a simple, fast and reliable way to perform testing in the physicians’ office, clinic or hospital point-of-care setting. The system and the first test for HbA1c are FDA 510(k) cleared and National Glycohemoglobin Standardization Program (NGSP) Certified, as well as CLIA waived. The HbA1c test is performed using simple pin-prick blood sampling and provides results in only three minutes.

Svein Lien, Axis-Shield CEO, commented: “We are very pleased that the FDA has granted CLIA waiver for the AFINION™ system and HbA1c test. There are more than 100,000 CLIA registered Physicians’ Office Laboratories in the United States, which can now use AFINION™, whereas without CLIA waiver, less than half were able to use the system. We look forward to the successful roll-out of AFINION™ in the United States market during the second half of 2006.”