Indeed there is nothing although again the principle

Soon, from a simple blood test, it will be possible to detect the beginning of cancer (breast, for example) while the patient is still no clinical signs. His treatment of chemotherapy, will be also chosen based on information obtained in the blood sample, and its effectiveness monitored through blood catches at regular intervals. To develop this treatment, the pharmaceutical is will be also supported on the same data to determine, among the patients with breast cancer, those likely to be more receptive to treatment.

The discovery

In all these situations, there will be recourse to what is called "biomarkers", that is an objective and reproducible measurable biological variables and which allow to identify a condition or to evaluate the response to treatment. Indeed, there is nothing although again the principle. The rate of sugar in the urine or cholesterol in the blood were before the letter, but very unsophisticated biomarkers. The development of biomarkers "modern" goes hand in hand with that of molecular biology and its avatars on a large scale are the Genomics (systematic study of the structure and the functioning of genes), proteomics (same principle, but for proteins) or, more recently, metabolomics (for small molecules synthesized by the body), etc. Automating the handling of biological samples and the use of the computer for the treatment of the data have given access to a workable to diagnose more early mass of biological information, follow the sick and develop treatments more custom.

If the beneficiaries of biomarkers, are in fine, the sick, many actors intervene in the process, from discovery to their use in routine. "Originally for the discovery of a new biomarker, there may be a pharmaceutical laboratory - even if biology is still rarely their hard-, but above all, more often, a company of diagnosis or a biotechnology company", explains Rasika Ramachandran, analyst at Frost & Sullivan. If the Swiss group Roche, including HER2 test prescription or non-the cancer drug Herceptin, is an exception, this is explained by its long-standing practice of a double diagnostic and pharmaceutical trade an early integration of biotechnology. Most of the other pharmaceutical (GSK, Merck, Pfizer, Sanofi-Aventis) accessing biomarkers via agreements with specialized companies. "Indeed, insofar as it is a nascent market, it is also a market very fragmented between many players", observes Rasika Ramachandran. The study that she has to devote to the topic number about 150 on the single European market.

Clinical validation

After the discovery of biomarker has its validation. This essential step must demonstrate that the biomarker variations are well correlated with the clinical course of the patient, and it by relying on a number of statistically significant case, which can last for several years and go, in some cases, up to several thousands or tens of thousands of patients. Health authorities, such as national agencies, the European Medicines Agency or the FDA, here play a critical role because it is they who determine, in collaboration with industry, standards and approaches that the biomarker is found to be relevant and authorized marketing. As soon as the clinical validation, CRO ("contract research organizations"), these companies to which pharmaceutical companies subcontract their clinical trials, occupy a central place, as well as in public research, specialized hospital platforms. Only they are able, for same disease, combine biomarkers based on different technologies. However, different types of biomarkers are often combined, including cancer. "There is an economic model to build these new diagnostic and monitoring tools," observes Maurice Chelli, project manager of the Bionest consulting company.

The economic model

There are of course the question of the cost of development and validation of the biomarker, up to several million euros. "But the biomarker value also depends on the medical service: How does save the health system through the better adequacy of treatment or the early discovery of his illness", continues Maurice Chelly. "In France, it will take time for such an approach", said Alain Huriez, President of TCLand and the Working Group of the LEEM on biomarkers. The tests developed in the public sphere are, indeed, essentially valued in terms of cost (115 euros about for anticancer prescription test, double for a test for diagnosing...). "In the United States, on the contrary, pursues Alain Huriez, potential savings related to biomarkers are already taken into account and the interest of personalized medicine." Also, the paying, private or public agencies, reimburse them. One may still ask if this justifies the Genomic Health company to sell 4,000 dollars the Oncotype DX test, which allows only administer properly the chemotherapy in breast cancer.