The history of the bio chips began with the analysis of DNA sequences
Simultaneously, the interaction of the analyzed DNA molecules with the immobilized DNA probes in each cell ensures parallel identification of multiple genomic targets. This makes it possible to use DNA bio chips as an effective molecular tool to identify clinically significant markers of pathogens and causes of socially significant diseases to monitor foodstuffs, plant raw materials, and possible ago- and natural biosensors. Bio chips can also contain cells with immobilized proteins or oligosaccharide at the same time. Moreover, each individual cell can be immobilized as an individual molecular probe, or their combinations, depending on the purpose of the experiment.
Interaction between different classes of molecules can take place in the form of "receptor-ligand", “antigen-antibody”, “enzyme-substrate” and so on.
Located in a cell immobilized Ligand of protein or non protein nature when interacting with a sample containing the compounds under analysis, forms a specific complex. At this stage, the analyzed compounds are separated from the mixture by their ability to bind specifically to immobilize ligands.
This allows simultaneous analysis of several biological objects on a single bio chip, implementing the principle of multiplex immunoassay based on multiple reactions of the interaction "antigen — antibody." a test is necessary for proteomics research, for the diagnosis of all types of diseases, which are characterized by changes in many parameters in the patient's blood serum. Personalized medicine implies a comprehensive examination of the patient that is, the analysis of his biological fluids on the maximum range of parameters.
It took 30 years since the first publication on the theory of interaction of DNA molecules with probes fixed on the bio chip substrate. During this period, the staff of the laboratory of biological micro arrays of the Institute of Biochemistry of the Russian Academy of Sciences have developed a universal methodology for the analysis of protein, and DNA markers on bio chips. A production line for the production of hydro gel bio chips with a capacity of up to 1 million per year was created and certified according to International standard ISO 13485.
Developed diagnostic test-systems Based on bio chips cover a wide spectrum of appendices - from identification of markers of medicinal stability of microorganisms and viruses, revealing of targets in a genome of the person associated with risk, and development of malignant tumors and efficiency of therapy, to multiplex immunoanalysis of protein markers in blood serum of the patient.
The first in the world methodology developed for the needs of practical medicine and approved by the Federal Service for Supervision in the Sphere of Health Care of the Russian Federation (Roszdravnadzor) for use in clinical practice, was a set of reagents, “TB-Biochip-1.” It was created to identify the genetic markers of the tuberculosis pathogen responsible for resistance to the first-line drugs — rifampicin and isoniazid.
Such bio chips for analysis of drug resistance of tuberculosis pathogen have been used in more than 30 institutions of anti-tuberculosis service of the Russian Federation, and CIS countries, bacteriological laboratories of the Federal Penitentiary Service, since, 2005. During this period, more than 500,000 tests were performed, and the diagnostic, economic, and clinical effectiveness of bio chips was proved, which made it possible to increase the numbest of cured patients with drug-resistant forms of tuberculosis by at least 3 times. The latest generation of TB bio chips in the form of the TB-TEST suite provides simultaneous detection of more than a hundred markers of resistance of the TB pathogen to current first and second-line drugs. This makes it possible to prescribe different doses of chemicals and to transfer patients to treatment with the latest medicines. This is extremely important given the current extremely limited spectrum of anti-tuberculosis drugs.