Axis-Shield announces US Launch of AFINIONTM
Dundee, Scotland, 28 December 2006: Axis-Shield (LSE:ASD, OSE:ASD), the international in vitro diagnostics company, today announces that it has released its flagship new AFINION™ point-of-care system for commercial sale in the USA. AFINION™ is an easy-to-use, fast and reliable instrument designed for the physician office laboratory (POL) and general point-of-care markets, and was a recent gold medal winner in the US-based Medical Design Excellence Awards (MDEA) competition, the prestigious awards programme for the medical technology community. The AFINION™ system and the first test (for HbA1c, used to monitor diabetes treatment) have US regulatory clearance, are National Glycohemoglobin Standardization Program (NGSP) certified and CLIA waived, which allows the system to be marketed to over 100,000 POL sites in the United States. The HbA1c test is performed using simple finger-stick blood sampling and provides results in only three minutes.
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. The AFINION™ and HbA1c test offer clear advantages over the competition, particularly in ease-of-use and time to result. The system will be marketed and sold in the United States exclusively by Abbott and its POL distribution partner Physician Sales & Service (PSS). Together the two companies have extensive sales coverage of the United States POL market.
Svein Lien, Axis-Shield CEO, commented: “We are now in a position to address the important United States market with our award-winning new system and look forward to working with Abbott and PSS to introduce AFINION™. We believe AFINION™ will become the instrument of choice for point-of-care HbA1c testing as customers recognize its simplicity, speed and reliability.”
Notes to Editors
About Clinical Laboratory Improvement Amendments (CLIA)
CLIA requires that clinical laboratories obtain a certificate from the US Secretary of Health and Human Services before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests with methodologies that are “so simple and accurate as to render the likelihood of erroneous results negligible” may obtain a certificate of waiver. Medical device manufacturers must submit a “CLIA waiver” application to the FDA, to show that their system meets the CLIA waived standard.
Axis-Shield is a global manufacturer of in vitro diagnostic kits with a focus on new markers in cardiovascular, rheumatoid, infectious and alcohol-related diseases, diabetes, dementia and near patient testing to facilitate improved patient management. News releases and company information are available at www.axis-shield.com
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- Axis-Shield plc
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