Axis-Shield Afinion HbA1c patent granted in Japan

Axis-Shield, the international in-vitro diagnostics company, today announces that it has received notice of approval for its Japanese patent application governing the measuring methodology for HbA1c within the Afinion™ cassette for detection of this important marker of diabetic patient compliance.

The patent protects technology which improves HbA1c stability, precision and accuracy and has resulted in a longer product shelf-life with improved performance. We continue to strengthen our Afinion™ related patent protection and this latest addition to our IP portfolio for Afinion™ complements US patent approval for design of the Afinion HbA1c cassette and notices of patent approval already received in Europe, China and Japan for applications covering the core technology.

The World Health Organisation estimates that more than 180 million people worldwide have diabetes and that this number is likely to more than double by 2030. Diabetes UK reports that the disease costs £9 billion a year in the UK, or 10% of the NHS budget, with about 500,000 cases a year remaining undiagnosed. It is generally agreed that HbA1c blood levels should be tested four times a year in people with Type I diabetes and twice yearly in those with Type II diabetes. As the HbA1c test does not require fasting before sample collection in the diagnosis of diabetes, unlike blood glucose, some authorities are suggesting broadening the utility of HbA1c testing to encompass diagnosis, particularly as global assay unit standardisation is now occurring. This should have the effect of increasing market potential for HbA1c testing in diabetes.

Ian Gilham, Axis-Shield CEO, commented: “We have developed a strong franchise for measuring HbA1c in diabetes through Afinion™ and NycoCard™ at the point-of-care, and on the Abbott AxSYM^® analyser in the hospital laboratory. Global IP protection for Afinion™ and the test menu is very important to us, particularly now this best-in-class point-of-care analyser and the HbA1c test are becoming more established as the ease-of-­use and reliability of the Afinion system are demonstrated.”