SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc.’s (NASDAQ: ILMN) NextSeq™ 550Dx platform and associated reagent kits received medical device registration in Russia, as have reagents for the MiSeq™Dx 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,” said 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.”
“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 the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Professor Mikhail Maschan.
Director of the Tomsk National Research Medical Center, correspondent member of the Russian Academy of Sciences, 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 to add 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 benefit from improved diagnosis and precision healthcare,” said Alexey Repik, R-Pharm Chairman of the Board.
About R-Pharm
R-Pharm Group introduces comprehensive solutions for the healthcare system and focuses on research, development, manufacturing and commercialization of pharmaceuticals, laboratory equipment and medical devices. R-Pharm’s mission is to increase the accessibility of advanced diagnostics, preventative care and therapy methods in Russia and abroad. More than 4500 employees of the group in 70 branches and 30 countries of the world do their best to provide as many people as possible with the necessary means to improve and prolong their lives. To learn more, visit www.rpharm.com.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com or connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.
Use of forward-looking statements
This release contains forward-looking statements that involve risks and uncertainties, including the expectation for lower costs related to the storing and managing of genomic data costs. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services, especially in international jurisdictions; (ii) our ability to deploy new products, services, and applications, and to expand the markets for our technology platforms; and (iii) the acceptance by customers of our newly launched products, which may or may not meet our and their expectations once deployed, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.