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NextSeq 550Dx Approved for Clinical Use in China

Continued expansion of clinical products further advances precision medicine globally

NextSeq 550Dx Approved for Clinical Use in China
2020/12/01
The NextSeq 550Dx received approval from China’s National Medical Products Administration (NMPA) for genetic testing and diagnosis, paving the way toward improved patient outcomes by harnessing the power of next-generation sequencing. Since obtaining United States FDA approval in 2017, the NextSeq 550Dx has been cleared for in vitro diagnostics in more than 40 countries. The NextSeq 550Dx is Illumina’s second clinical-grade sequencer to receive NMPA regulatory approval, following the 2018 approval of the MiSeq Dx. 

The NextSeq 550Dx’s regulatory approval is another important milestone in Illumina’s development in China, as well as an achievement rooted in our continuous investment in and commitment to bringing innovative products and technologies to this vibrant market.

As China’s healthcare industry continues to evolve, clinicians are increasingly recognizing the value for NGS technology, as seen by rising demands for higher throughput sequencing. This rapid growth is set to make a significant contribution to the government’s Healthy China 2030 initiative. Importantly, people throughout China stand to benefit from these advancements, whether related to oncology, reproductive health, and genetic disease, among others. 

“Since entering China, Illumina has worked with Chinese partners to promote the development and adoption of NGS in the clinical field,” said Li Qing, Vice President and General Manager of Greater China at Illumina. “The NextSeq 550Dx’s regulatory approval is another important milestone in Illumina’s development in China, as well as an achievement rooted in our continuous investment in and commitment to bringing innovative products and technologies to this vibrant market.” 

The NextSeq 550Dx system offers users the ability to perform NGS for in vitro diagnostic or research applications using a single, easy-to-use system. Designed and validated for the clinical market, the instrument harnesses Illumina’s industry-leading sequencing by synthesis (SBS) chemistry, giving laboratories high confidence in their results.  

With this approval, Illumina welcomes a wide range of IVD partners in China to develop testing products for clinical applications on the NextSeq 550Dx.  

In 2019 Illumina announced an agreement with European-based QIAGEN to develop and globally commercialize IVD kits to be used on the NextSeq 550Dx. Through this partnership, QIAGEN is building a broad menu of IVD tests on Illumina’s diagnostic sequencers by leveraging its market leading companion diagnostic capabilities and Sample to Insight solutions, thereby enhancing both companies’ channel reach and presence in the IVD market. 

“Illumina and QIAGEN have brought together our highly complementary capabilities to advance the use of NGS technologies in clinical decision-making,” says Jonathan Arnold, Vice President and Head of Oncology and Precision Diagnostics at QIAGEN. “The NextSeq 550Dx offers a robust diagnostic NGS product portfolio capable of covering a broad range of clinical applications and it’s been a great addition to our shared vision of using this powerful technology to improve the outcomes for patients worldwide.” 

Continued expansion of these products in the clinical lab will further advance the understanding of genetics and enable precision medicine. Lisa Whiteley, Lead Senior Technologist at Henry Ford Health System in Detroit, Michigan notes: “The NextSeq 500Dx is a great option for medium-throughput molecular pathology labs that want to offer valuable and cost-effective onsite testing. We are currently using the NextSeq 550Dx for solid tumor testing. The sequencer is easy to use, easy to maintain, and has cut our turn-around time down significantly.”  

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