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Illumina and R-Pharm Secure Registration for 2 Complete IVD Sequencing Platforms in Russia

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March 5, 2021

Illumina, Inc. reports their Illumina’s NextSeq™ 550Dx platform and associated reagents kit have received medical device registration in Russia, as have reagents for the MiSeq™Dx which was approved previously as a medical device.

The company notes that both of these in vitro diagnostic (IVD)-ready solutions are available to customers and third-party developers to create diagnostic solutions using the technology. These registrations will catalyze the expansion of sequencing-based clinical diagnostics across the country.

Sequencing platforms, and the reagents that drive them, must be approved separately in Russia by the medical device regulatory agency, Roszdravnadzor. Illumina’s strategic partner in Russia and CIS, R-Pharm, has led the regulatory process. This is the first approval of complete sets of sequencing instruments plus reagents.

“Having the two IVD-platforms available to assay developers to expand the clinical use of NGS-based molecular diagnostics will be a great boost to testing for genetic diseases and oncology in Russia,” said Paula Dowdy, SVP, GM, Illumina, EMEA. “The NextSeq 550Dx is ideal for high throughput sequencing at large, federal hospitals, and the desktop MiSeqDx is well suited to the laboratory facilities of standard clinical centers.”

“These registrations are a significant step in bringing NGS technologies closer to patients, many of whom live near the smaller municipal and regional clinics. Bringing NGS diagnostics, with accurate and validated results, will be a huge benefit to patients,” said Deputy Director-General of Dmitry Rogachev NMIC for Children Haematology, Professor Mikhail Maschan.

Director of Tomsk NIMC, the correspondent member of RAS Vadim Stepanov, said: “Genetics and molecular biology are the core of clinical science because the majority of diseases originate from genetic mechanisms in cells, tissues, and organs. Registration of Illumina’s products as medical devices allows adding the most modern technologies to clinical practice.”

“We are pleased that our partnership with Illumina, a global leader in human genome sequencing, will help Russian patients to benefit from improved diagnosis and precision healthcare,” said Alexey Repik, R-Pharm Chairman of the Board.

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