OBJECTIVES: An application of predictive and pharmacogenetic tests in appointment of targeted anti-cancer therapy and predict response to treatment. Considering significant practical necessity of molecular-genetic methods for health care and high cost, it is important to evaluate these technologies in terms of health economics. METHODS: A systematic review of articles has been conducted using databases PubMed, The Cochrane Library, and published reports and market reviews. RESULTS: In the period from 2007 to 2012 it is estimated the world market in vitro diagnostic (IVD) is increasing due to the development of molecular diagnostic tests and rapid test kits. Experts point out that a key factor in the growth segment of molecular diagnostics in recent years has been precisely the emergence of new oncology tests to prescribe targeted therapy. At the moment, in IVD diagnostics segment in Russia market is forecasted growth rate for 2014  at 10-20%. Price of tests for oncology biomarkers depends on the technology: - for most routine immunological and chemical tests is between 10 and 15 USD; - for molecular genetic tests costs varies from 40 to 4000 USD per procedure. In addition to practiced in Russian Federation KRAS- and EGFR-testing, in this review discussed the practical value of: testing EML4-ALK mutation for crizotinib in non-small lung cancer; BRAF V600E-testing for vemurafenib in melanoma; HER2/neu-testing for trastuzumab in breast cancer. Thus, the Russian segment of the cancer diagnostics market is the fast-growing market.

However, the analysis of the literature showed that until that time in the Russian Federation was not conducted clinical and economic evaluation of these medical technologies. CONCLUSIONS: The analysis revealed that evaluation of diagnostic test systems in oncology from the point of view of health economics of the Russian Federation is a topical field for research and requires a rigorous analysis.