Point-of-Care System Launched in the United States

An easy-to-use, fast, and reliable instrument designed for the physician office laboratory (POL) and general point-of-care markets has been launched in the United States. The instrument measures glycolated hemoglobin (HbA1c) and C-reactive protein (CRP).

Called Afinion, the analyzer is a product of Axis Shield (Norway, Oslo). It was a recent gold medal winner in the U.S.-based Medical Design Excellence Awards (MDEA) competition, the awards program 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 clinical laboratory approved amendments (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 currently used tests, 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.



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