New Detection System for Vitamin B12

The body cannot make its own supplies of vitamin B12 and, lacking an adequate dietary supply from animal sources or enriched cereals, up to 20 million people may suffer anemia, risk nerve damage, and even face death. Although the holotc complex carries only 20% of the body's vitamin B12, the other 80% is not as significant since it is not available for uptake by the cells. Current diagnostic techniques measure the total amount of B12 in the blood. Because such tests do not discriminate between holotc and the inactive vitamin, they can be misleading and show a healthy result for patients with too little active B12.

Axis-Shield ASA in Oslo, Norway (a subsidiary of Axis-Shield in Dundee, Scotland), teamed up with academics at the University Hospital of Aarhus (Denmark; www.auh.dk) and pioneered a way to note early warning signs of harmful B12 deficits. Based on their findings, they developed a test called holoTC.

"Current methods are technically good, but have low diagnostic sensitivity. The holoTC test isolates vitamin B12, enabling early identification of patients with B12 malabsorption,” notes Lars Oming, project manager at Axis-Shield.

Until recently, it was not possible to develop suitable methods to measure holotc. "The early detection of this key indicator has allowed our laboratories to develop measurement prototypes,” explained Professor Ebba Nexo, of University Hospital of Aarhus. Now the researchers say they have produces a simple, automated, adaptable radioimmunoassay that they expect will take the largest share of the world market for vitamin B12 diagnostic tests.

The partners will share the rewards of their success. Axis-Shield in the United Kingdom will oversee the marketing and sales of the diagnostic test, while the University of Aarthus will benefit from royalties and sales of essential test materials.

In February, 2004, the U.S. Food and Drug Administration (FDA) cleared the radioimmunoassay for holoTC for the measurement of biologically available vitamin B12. Axis-Shield notes that malabsorption of vitamin B12 is a major problem in elderly populations, and that low levels of holoTC could be associated with neurologic damage and Alzheimer's disease.

"We are pleased to have met U.S. regulatory requirements for the first test for this potentially very important new marker. We expect market demand for holoTC to increase significantly as nonradioactive and automated assay formats are developed by ourselves and our partners,” observed Svein Lien, CEO of Axis-Shield.




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Axis-Shield
U. Hospital of Aarhus