The increased dynamics of scientific and technological progress in gene diagnostics, its practical relevance and importance for people’s lives and health, as well as the state’s strategic orientation towards the development of genetic technologies for healthcare and the transition to personalized medicine they provide, objectively actualize the scientific development of the optimal legal form for this group of social relations.

The unique properties of gene diagnostics, expressed in high prognosis, potential significance for the family of the person in several generations and entire groups of the population, the immutability of the human genetic constitution, contain an increased risk of violation of the subjective rights of citizens and determine the need for their special and enhanced legal protection. The main problem is seen in the growing prognostic potential of genetic research and the emerging gap between modern diagnostic capabilities, on the one hand, and prevention and treatment, on the other. The burden of knowledge about a genetic predisposition to a disease in the absence of real chances to reduce the risk of its occurrence or eliminate or alleviate its manifestations becomes fatal and becomes unbearable for the patient.

To resolve the problem the article, with the application of the comparative legal method, raises and reveals questions about the legal assessment of the possibilities and risks of the development of gene diagnostics, the essence and target orientation of special legal regulation in this area, the variability of its systemic organization, genetic «exceptionalism», differentiation of legal regimes of various types of gene diagnostics, the right to bioinformational self-determination, including the right to know and the right not to know one’s genetic data, the grounds and limits of their restrictions, genetic counseling, quality standards in the field of gene diagnostics, especially the requirement for compliance with the modern level development of science and technology.

The results of their scientific and practical understanding seem useful from the point of view of the prospects for institutionalization and the formation of the conceptual foundations of gene diagnostics in domestic law.