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.