San Diego-based Illumina’s NextSeq 550Dx platform and associated reagent kits received medical device registration in Russia, as have reagents for the MiSeqDx which was approved previously as a medical device. 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, led the regulatory process and 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 Next Generation Sequencing-based (NGS) molecular diagnostics will be a great boost to testing for genetic diseases and oncology in Russia,” says Paula Dowdy, senior vice president and general manager of Illumina, Europe, Middle East and Africa. “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.”
“We are pleased that our partnership with Illumina, a global leader in human genome sequencing, will help Russian patients benefit from improved diagnosis and precision healthcare,” says Alexey Repik, R-Pharm chairman of the board.
Featured image: Illumina NextSeq 550Dx (Courtesy: Illumina)