The EUREKA E! 2334 DIAGNOSTICS COCANAL project has led to the development of a new generation of monoclonal antibodies and enzyme-linked immunosorbent assay (ELISA) diagnostic kits for faster, more effective clinical diagnosis as well as for medical research. Key applications include screening of transplants and early detection of cancers, particularly of the colon. The results of the five-year project that brought together scientists from the Czech Republic, Germany and the People’s Republic of China (PRC) are already being used in hospitals and laboratories. Diagnostic kits are markedly reducing risks in the implantation of embryos from in vitro fertilisation in assisted reproduction.

The body’s immune system provides a smart form of defence against diseases. It identifies antigens – substances foreign to the body, such as bacteria, viruses and other infectious agents – as intruders. Proteins known as antibodies seek out these intruders and destroy them. Antibodies are clever weapons, each binding to a particular intruder. It is this ability that makes vaccinations possible – samples of weakened bacteria or viruses can be introduced to the body to stimulate production of the necessary antibodies.

Moreover, the specificity of the antibody reaction can be exploited in early diagnosis of a wide variety of illnesses. For example, it is possible to develop tumour-specific markers for cancer detection based on monoclonal antibodies – that is antibodies coming from only one type of cell. The antibody reaction can also be used to detect the presence of viruses, bacteria and other abnormal or unwanted substances in the blood, in water or in the air.

ELISA kits use these immunological reactions both to detect the presence of an antibody or an antigen in a sample and to determine the concentration. Such kits make use of two antibodies, one reacting to the antigen and the other coupled to an enzyme that provides a colour or fluorescent signal.

Clinical diagnostics is a €13 billion industry worldwide that is becoming increasingly dominated by antibody-based products. So-called immunodiagnostics now account for a third of the total market and are increasing at a rate of 15% per annum. New diagnostic assays have a short lead time to market, usually less than two years, and offer a rapid return on investment. Monoclonal antibodies are a basic part of these new diagnostics.

DIAGNOSTICS COCANAL set out to improve identification of tumour-specific markers at the initiative of Exbio Praha. This Czech company specialises in the development and manufacture of monoclonal antibodies for research and diagnostics. It is the leading company in the Czech Republic in this field and has a good position in Europe.

The most interesting application is in the control of the transfer of embryos in assisted reproduction. Use of our diagnostic kits will reduce failure rates by 50%. 

Dr Vladimir Viklicky,
Exbio Praha, Czech Republic

The main focus of the EUREKA project was the construction of a new generation of monoclonal antibodies with very specific attributes to enable low cost and rapid diagnostics or detection of the target antigens. Diagnostics using the HLA-G specific antibody selected are useful in various pathological situations, such as cancers, transplantations and the successful implantation of fertilised embryos.

“We set out to construct new antibodies and diagnostic kits that can be used in research and development of different fields of medicine,” explains Dr Vladimir Viklicky, founder of Exbio. “The most interesting application is in the control of the transfer of embryos in assisted reproduction. Use of these diagnostic kits will reduce failure rates by 50%.”

Monoclonal antibody technology is based on a hybrid cell fusion process that combines naturally produced antibodies with a class of cells that grow continually in culture. The resulting cell ‘factory’ fuses tumour cells that replicate endlessly with mammalian cells producing antibodies to provide a ‘hybridoma’ cell mass.

Exbio entered the antibody market as a spin-off from the Czech Academy of Sciences in 1990. Researchers at the Institute of Molecular Genetics in the former Czechoslovakia started producing specific antibodies at the end of the 1970s. “In 1980, our research group prepared the well characterised monoclonal antibody TU-01,” says Dr Viklicky. “The number of developed and characterised unique monoclonal antibodies continuously increased. Hybridoma technology in Czechoslovakia reached a high quality.”

Our products are already being used in clinics, hospitals and laboratories for diagnosis and research.”

The management of the Institute became aware not only of the scientific impact of developed antibodies, but also of their economic potential. “The former head of the Institute of Molecular Genetics convinced communist bosses of the importance of monoclonal antibodies for research, diagnostic and therapeutic purposes, and established a technology unit that manufactured the antibodies we developed to meet the demands of national socialist industry,” explains Dr Viklicky. This was the origin of Exbio.

The idea for the EUREKA project came from Professor Horejsi of the Czech Academy of Sciences as a scientific goal, with the support of Exbio for eventual development as a practical product. PRC partner Global Biotech joined with the intention of co-operating in the development of diagnostic kits for the detection of colon cancer, initially for use in China, Singapore and the Middle East.

“EUREKA played a major role in financing this project,” says Dr Viklicky. “We were able to exploit the results commercially very quickly after the end of the project. Our products are already being used in clinics, hospitals and laboratories for diagnosis and research.” Co-operation between Exbio and German university partner TU Muenchen is also leading to use of the new monoclonal antibodies for automated testing as a part of continuous air quality safety control in EU countries.

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