Illumina's NextSeq™ 550Dx next-generation sequencing (NGS) platform (pictured), associated reagent kits, and reagents for the company’s MiSeq™Dx have all been approved for use in Russia by the country’s medical device regulatory agency, Roszdravnadzor. [Illumina]

Illumina said that its NextSeq 550Dx next-generation sequencing (NGS) platform, associated reagent kits, and reagents for the company’s MiSeq Dx have all been approved for use in Russia by the country’s medical device regulatory agency, Roszdravnadzor.

Roszdravnadzor has granted medical device registration to NextSeq 550Dx, which Illumina launched in 2017 as its second FDA-regulated and CE-IVD marked clinical NGS system, with the goal of extending NGS to clinical labs.

The agency also granted registration for reagents associated with both NextSeq 550Dx and MiSeq Dx, which received FDA premarket clearance in 2013  as Illumina’s first NGS sequencer approved for the clinical market. MiSeq Dx has been previously approved for use as a medical device in Russia, where sequencing platforms and their reagents require separate approvals from Roszdravnadzor.

NextSeq 550Dx and the reagents are expected to reach Russian customers in the second quarter, Timofei Rassokhin, Illumina’s country manager for Russia and Commonwealth of Independent States (CIS), told Clinical OMICs.

“Our customers will range from private diagnostic labs to hospitals and medical research facilities of the Ministry of Health and RosPotrebNadzor (Russian Agency for Sanitary Control and Social Well-being),” Rassokhin said.

NextSeq 550Dx and MiSeq Dx are in vitro diagnostic (IVD)-ready solutions that Illumina said are being made available to customers and third-party developers.

Those customers and developers can already access Illumina’s newer NGS sequencing platforms, NextSeq 1000 and NextSeq 2000 Sequencing Systems. Soon after both systems were launched last year, Russia became one of the first markets in the Europe-Middle East-Asia (EMEA) region to acquire NextSeq 2000, Rassokhin said.

Professor Mikhail Maschan, deputy Director General of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, said in a statement that the 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,” Maschan said.

Illumina’s strategic partner in Russia and CIS, R-Pharm, led the regulatory process that culminated in the registrations—which marked the first time the agency had approved a complete set of sequencing instruments plus reagents.

Illumina said the registrations are expected to facilitate clinical diagnostics across Russia.

“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,” Paula Dowdy, Senior Vice President and General Manager of Illumina, Europe Middle East and Africa, added. “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.”

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