SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ:ILMN) today announced that its MiSeq™Dx Sequencing System received the approval certificate from the China National Drug Administration (CNDA). This is Illumina’s first CNDA-cleared, next-generation sequencing (NGS) system in China. In accordance with the clearance, Illumina can now market and sell the MiSeqDx Sequencing System to hospitals and other medical institutions for in-vitro diagnostic (IVD) testing throughout China.
Designed specifically for the clinical laboratory environment, the MiSeqDx Sequencing System is a benchtop sequencer that incorporates an easy-to-use workflow and data output tailored to the diverse needs of clinical labs. Taking advantage of proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx Sequencing System provides IVD developers the tools to create accurate diagnostic testing. Additionally, integrated software enables run setup, sample tracking, user management, audit trails and data interpretation.
“The clearance of the MiSeqDx in China is a significant milestone for Illumina because it provides more opportunities for NGS,” said Garret Hampton, Executive Vice President of Clinical Genomics at Illumina. “More medical institutions and patients will now have access to the latest NGS technology. We are encouraging more clinical companies to select the MiSeqDx System to develop new clinical assays and to help provide needed solutions to some of China’s greatest health challenges.”
The MiSeqDx Sequencing System now has regulatory approval in the United States, China, Canada, Argentina, European countries recognizing the CE-IVD mark, Australia, South Korea, Singapore, Thailand and the Philippines.
For more information on the MiSeqDx Sequencing System, please visit www.illumina.com/miseqdx.
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 and follow @illumina.
Use of forward-looking statements
This release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements are based on our expectations as of the date of this release and may differ materially from actual future events or results. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are (i) our ability to further develop and commercialize our instruments and consumables, including our diagnostic kit products, and to deploy new products such as the MiSeq™Dx System, services and applications, and expand the markets for our technology platforms; (ii) our ability to manufacture robust instrumentation and consumables; (iii) our ability to successfully identify and integrate acquired technologies, products or businesses; (iv) the future conduct and growth of the business and the markets in which we operate; and (v) challenges inherent in developing, manufacturing, and launching new products and services, 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.