Illumina and R-Pharm have obtained medical device registration for two complete in vitro diagnostic (IVD) sequencing platforms in Russia.
They include the NextSeq 550Dx sequencing platform, associated reagent kits, and reagents for the MiSeq Dx sequencer, which was earlier approved in the country.
The regulatory process was led by R-Pharm, Illumina’s strategic partner in Russia and the Commonwealth of Independent States. It the first approval of complete sets of sequencing instruments and reagents.
The sequencing platforms and reagents require separate approvals from the Russian medical device regulatory agency, Roszdravnadzor.
Illumina Europe Middle East and Africa senior vice-president and general manager Paula Dowdy said: “Having the two IVD-platforms available to assay developers to expand the clinical use of next-generation sequencing-based (NGS) molecular diagnostics will be a great boost to testing for genetic diseases and oncology in 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 centres.”
The registrations in Russia will accelerate the expansion of the company’s sequencing-based clinical diagnostics across the country.
The company said that the IVD-ready sequencing platforms are available to customers, as well as the third-party developers to create diagnostic solutions using the technology.
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology deputy director-general Mikhail Maschan said: “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.”