New studies support utility of Axis-Shield Active-B12 test

Axis-Shield, the international in vitro diagnostics company, today announces that the utility of its patented assay for Active-B₁₂, or holo-transcobalamin, was strongly supported by leading academics at an important Workshop during the EuroMedLab 2007 meeting this week in Amsterdam.

Vitamin B₁₂ deficiency is an increasing problem, particularly in elderly populations and in those taking proton pump inhibitors and H₂ antagonist drugs which inhibit gastric acid secretion, commonly for the treatment of stomach ulcers. Lack of this vitamin has been associated with increased risk of heart disease, stroke and cognitive decline, as well as with haematological abnormalities. Last year Abbott Diagnostics launched Axis-Shield’s assay on its widely-placed automated AxSYM^® laboratory analyser, as a more effective method of determining vitamin B₁₂ deficiency than total B₁₂ assays (typically 30% of which are found to be indeterminate and requiring repetition). Active-B₁₂ detects only the biologically available component of circulating vitamin B₁₂ which is around 20% of the total.

Professor Jan Lindemans from the Erasmus University in Rotterdam reported on a Dutch multicentre study to examine the diagnostic value of the AxSYM^® automated Active-B₁₂ assay. The investigators concluded that the test met analytical performance criteria and that in the study it was superior to total B₁₂ measurement in the detection of vitamin B₁₂ deficiency. This finding was supported by Professor John Scott of Trinity College in Dublin who showed additional data which attested that Active-B₁₂ “is a more sensitive and specific predictor of metabolic B₁₂ deficiency than commonly used commercial assays for total serum B₁₂”. Professor Hans Schneider, Director of Pathology at the Alfred Pathology Service in Melbourne, also confirmed the value of Active-B₁₂ testing over total B₁₂ and Active B-₁₂ measurement now forms a key part of his routine laboratory testing for B₁₂ deficiency.

Svein Lien, Axis-Shield CEO, commented: “This Workshop has confirmed the utility of our marker and has questioned the need for the conventional measurement of total serum vitamin B₁₂. Working with Abbott we shall continue to promote this important message and build the market for Active-B₁₂ testing, which has the potential to replace a significant part of the current 35 million total B₁₂ test market.”