NEW YORK – Illumina said on Friday that it has received medical device registration in Russia for its NextSeq 550Dx sequencing platform, associated reagent kits, and reagents for the MiSeq Dx sequencer, which was previously approved in Russia.
R-Pharm, Illumina's strategic partner in Russia and the Commonwealth of Independent States (CIS), led the regulatory process, which requires separate approvals of sequencing platforms and reagents by the Russian medical device regulatory agency, Roszdravnadzor.
"These registrations are a significant step in bringing NGS technologies closer to patients, many of whom live near the smaller municipal and regional clinics," said Mikhail Maschan, director general of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology, and Immunology, in a statement.
"Having the two IVD platforms available to assay developers to expand the clinical use of next-generation sequencing-based molecular diagnostics will be a great boost to testing for genetic diseases and oncology in Russia," said Paula Dowdy, senior VP and general manager of Illumina for Europe, the Middle East, and Africa.
The Russia registration follows approvals of Illumina's sequencing platforms for clinical use in other countries. In December, for example, China's National Medical Products Administration approved the NextSeq 550Dx for genetic testing and diagnosis.