Vitamin B12 is essential to human life. The body cannot make its own supplies and without an adequate dietary supply from animal sources or enriched cereals, up to 20 million people can suffer anaemia, risk nerve damage and even death. Unfortunately, vitamin B12 deficiency can go undetected for several years, remaining invisible to doctors while the likelihood of irreversible cell damage increases.
Under EUREKA project E! 2263 HOLOTC, Norwegian diagnostics company Axis Shield teamed up with Danish academics to find a way to pick up early warning signs of potentially harmful B12 deficits. The project pioneered a unique B12 detection system, which tracks concentrations of holotc (short for holo-transcobalamin), a biologically active complex of the vitamin plus a carrier protein. Although the holotc complex carries only 20% of the body's vitamin B12, the other 80% is not nearly as significant since it is effectively not available for uptake by the cells. Current diagnostic techniques measure the total amount of B12 in the blood. Because these tests do not discriminate between holotc and the inactive vitamin, they can misleadingly return a healthy result for patients with too little active B12.
Lars Orning, the Project Manager from Axis Shield, says 'current methods are technically good, but have low diagnostic sensitivity. The HOLOTC test isolates vitamin B12, enabling early identification of patients with B12 malabsorption.'
EUREKA has been extremely helpful for us, since it allowed the important progression from pure research to the work needed to make the assay ready for clinical testing.
University Hospital of Aarhus
HOLOTC is well on the way to producing a simple, automated, adaptable radio immunoassay which the partners expect will take the largest share of the world market for vitamin B12 diagnostic tests.
Ebba Nexo of University Hospital of Aarhus, Denmark, describes how until recently it has not been possible to develop suitable methods to measure holotc. 'The early detection of this key indicator has allowed our laboratories to develop measurement prototypes.' As a result, 'HOLOTC is well on the road to producing simple, adaptable assays which should take the largest share of the world market for vitamin B12 diagnosis.'
The partners will share the fruits of their success. Axis Shield will market and sell the diagnostic test, while the University of Aarhus will benefit from royalties and sales of essential test materials.
The project has received an enthusiastic response from the medical community. Nexo says 'I've been invited to give lectures about HOLOTC at several international meetings, and we've received an EU grant to finish the work started under the project. EUREKA has been extremely helpful for us, since it allowed the important progression from pure research to the work needed to make the assay ready for clinical testing.'