Illumina NextSeq 550 Dx

Main article: DNA sequencing

2021: Registration in the Russian Federation

The group of companies R-Pharm"" on March 16, 2021 announced the completion of registration on the territory of the RUSSIAN FEDERATION complex of equipment for sequencing the latest generation (Next Generation Sequencing (NGS)), developed by a representative in the field of genetic research company. Illumina Registered products are a universal diagnostic solution based on NGS technology, designed for use not only in scientific institutions, but also in real clinical practice - hospitals, clinics, oncological dispensaries.

The final stage of registration at the end of January 2021 was the receipt of registration certificates for the sequencer NextSeqTM550 Dx and a set of reagents NextSeq 550 Dx v2.5 for nucleic acid sequencing.

The NextSeq550 Dx sequenator from Illumina is considered the ideal device for large (federal) clinical centers. High power combined with reading speed allows you to sequence a complete human exome and is suitable for large oncological analysis, research of hereditary diseases, chromosomal abberations and aneuploidies.

In December 2020, R-Pharm received a registration certificate for a set of reagents MiSeqTM Dx v3, developed for another model of the sequencer MiSeq Dx, introduced to the domestic market earlier.

Thus, as of March 2021, the R-Farm group of companies, which is the official representative of Illumina in Russia, registered two ready-made IVD solutions from Illumina in the country. This opens up opportunities for a qualitative leap in the development of genetic diagnostics in Russia.

Thanks to the open platform of Illumina, the registration of sequencers and reagents will allow all interested developers, both Russian and international, to create their own diagnostic solutions based on NGS technology.

The application of NGS technology in real clinical practice opens up truly good prospects in terms of timely and high-precision diagnosis of oncological and genetic diseases. We are pleased that a partnership with our colleagues from Illumina, a human genome sequencing company whose equipment provides three quarters of the world's sequencing volumes, will allow Russian patients to learn about health problems at really very early stages and receive timely and effective therapy, "emphasizes Alexey Repik, chairman of the R-Farm board.

Registering Illumina devices and basic reagents as medical products is a huge step bringing NGS technologies closer to patients. Most patients are outside federal centers that have scientific funding to use the technology, undergoing treatment in municipal and regional clinics. The possibility of using technology in these centers is to enter the huge market of clinical medicine. Moreover, the use of NGS for clinical purposes, unlike academic use, meets all the characteristics of medical analysis, it gives a predictable and validated result that is suitable for clinical use and is fully used in the interests of the patient, "emphasizes Deputy Director General of the NMIC for pediatric hematology, oncology and immunology named after Dmitry Rogachev, Professor Mikhail Maschan.

The plans of the R-Pharm group of companies include the registration of IVD solutions data in the CIS countries, as well as the introduction of other Illumina diagnostic equipment to the domestic market.