The biotechnology company Araclon Biotech recently organised the initial coordination meeting in Zaragoza of all the participants in a European study that will start this month of February. It will have a twofold objective: validating their ABtest kit as the optimum tool for measuring beta-amyloid in blood, and validating the correct measurement of this protein in blood as a biomarker for the disease in its initial stages.  

A total of 14 centres selected in Sweden, Italy, France and Spain will participate in the study, and a large proportion of the world's leaders in clinical research on Alzheimer's disease will be amongst the principal researchers.

Last year the company carried out a pilot study, in collaboration with Fundació ACE (Institut Català de Neorociències Aplicades, the Catalan Institute of Applied Neurosciences) led by Dr. Mercè Boada, Dr. Pablo Martínez Lage and Luis Tárraga. The study involved using their diagnostic kits (ABtest 40 and ABtest 42) with a sample of 40 individuals. This pilot study demonstrated that their kit discriminates with a high level of sensitivity and specificity between healthy individuals and individuals who present mild cognitive impairment and Alzheimer's disease.

Objectives of the study

Now the Spanish biotechnological company -which is participated by the Viamed Group-, wants to support the data from the pilot study with statistically sufficient data to conclude, if  the results agree with those obtained in the pilot study, that the correct measurement of the total amount of beta-amyloid 40 and 42 in blood is a good biomarker for the diagnosis of the disease in the initial stages.  

To achieve this, a study will be carried out over two years with around 400 individuals, consisting of both healthy people and people with cognitive impairment.  The aim is to assess whether the individuals with cognitive impairment and a high initial level of beta amyloid in blood constitute the group with the highest rate of progression to Alzheimer's disease during the following two years.  

In this way, the company hopes to corroborate the measurement and quantification of this biomarker as a key variable for establishing an early diagnosis of the illness.  Furthermore, their ABtest kit would be validated as a suitable tool for carrying out this type of measurement, through having a sufficiently low detection limit on a par with its ability to measure the whole of the beta-amyloid in blood (beta-amyloid pool).

Araclon Biotech considers as a "success" the fact that a panel of world experts in clinical research wants to participate in the study and contribute their experience and prestige to the development and validation of the clinical usefulness of the diagnostic kit developed by Spanish biotechnology.

Characteristics of the ABtest

The Araclon Biotech ABtest kit is able to measure the beta-amyloid found in the whole of an individual's blood pool (not only the free beta-amyloid in the plasma, but also the beta-amyloid bound to other components of the blood, namely the cells, lipids and proteins). The kit has a very low detection limit which makes it possible to find significant differences between the levels of beta-amyloid in healthy individuals compared to levels in people who are unwell and those who have mild cognitive impairment.

Up until now, measurements made of this protein in blood have been limited to measuring the amount of free beta-amyloid in plasma, which represents only 15% of the total.  That is to say, the total amount of this protein in blood has not been measured as there has not been an adequate tool available, nor an optimum method of treating the sample.  

 Pilar de la Huerta, the Managing Director of Araclon Biotech, stressed that "for us, obtaining the cooperation of some of the best clinical researchers in Europe who value the project we are developing, is a great success.  We feel sure that the results obtained from the study will back up the data obtained in the pilot study.  In any case, the success of having caught the attention and interest of a panel of experts of this calibre in itself represents a great success for the company�.

Presence in International Forums and Conferences
Araclon Biotech attended three international conferences during January 2010 to present their project. Their aim was to find partners, licensees or collaborators to market their ABtest at a global level.
Bio Business 2010, held in London, Biotech Showcase, held in San Francisco (USA), and BioPartnering North America held in Vancouver (Canada) were the three international events which the company attended as speakers, and where they generated a high level of interest.