Skip to main content
Premium Trial:

Request an Annual Quote

China NMPA Approves Illumina NextSeq 550Dx Sequencer for Genetic Testing and Diagnosis

NEW YORK – Illumina said on Tuesday that China's National Medical Products Administration (NMPA) has approved the firm's NextSeq 550Dx instrument for genetic testing and diagnosis.

"Since entering China, Illumina has worked with Chinese partners to promote the development and adoption of NGS in the clinical field," Li Qing, Illumina VP and general manager of greater China, said in a statement. "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."

Along with the MiSeq Dx, Illumina now has two clinical-grade sequencers approved by NMPA. Illumina has partnered with Chinese molecular diagnostics firms Burning Rock Dx and AnchorDx to develop clinical oncology tests in China.

The NextSeq 550Dx is also approved in the US, where the US Food and Drug Administration cleared it for in vitro diagnostics in 2017, as well as 40 other countries.

The Scan

Study Examines Insights Gained by Adjunct Trio RNA Sequencing in Complex Pediatric Disease Cases

Researchers in AJHG explore the diagnostic utility of adding parent-child RNA-seq to genome sequencing in dozens of families with complex, undiagnosed genetic disease.

Clinical Genomic Lab Survey Looks at Workforce Needs

Investigators use a survey approach in Genetics in Medicine Open to assess technologist applications, retention, and workforce gaps at molecular genetics and clinical cytogenetics labs in the US.

Study Considers Gene Regulatory Features Available by Sequence-Based Modeling

Investigators in Genome Biology set sequence-based models against observational and perturbation assay data, finding distal enhancer models lag behind promoter predictions.

Genetic Testing Approach Explores Origins of Blastocyst Aneuploidy

Investigators in AJHG distinguish between aneuploidy events related to meiotic missegregation in haploid cells and those involving post-zygotic mitotic errors and mosaicism.