Illumina receives 1st approval in China for its MiSeqDx sequencing system

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With a certificate from the China National Drug Administration, Illumina has begun encouraging more clinical laboratories to choose the MiSeqDx system to develop new clinical assays. (Illumina)

Illumina received the first official Chinese government clearance for one of its next-generation sequencing systems, allowing the company to market and sell its own benchtop MiSeqDx device to hospitals and other institutions for in vitro diagnostic testing throughout the country.

Previously, the San Diego-based manufacturer made inroads into the Chinese market through diagnostics partnerships with local companies for the development of specific genetic tests for a variety of diseases and applications.

In 2015 alone, for example, Illumina inked separate deals with Novogene and Annoroad to develop prenatal DNA screening tests as well as next-generation sequencing cancer diagnostic agreements with Novogene, Amoy Diagnostics and Burning Rock.

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“The clearance of the MiSeqDx in China is a significant milestone for Illumina because it provides more opportunities for NGS,” Garret Hampton, Illumina’s executive VP of Clinical Genomics, said in a statement.

Armed with an approval certificate from the China National Drug Administration, Illumina has begun encouraging more clinical laboratory companies to choose the MiSeqDx system for the development of new clinical assays, Hampton said.

For the first half of this year, Illumina reported $185 million in revenue from China, Taiwan and Hong Kong—about 11% of the company’s total—up from $134 million in the same six-month period the year before and outpacing the rest of the Asia-Pacific region.

In addition, Illumina launched its BaseSpace cloud-based sequencing hub in China in January, providing data storage, management and analysis services hosted by Beijing Sinnet Technology Co. Ltd.

Illumina will face competition from already-established DNA companies, including Beijing-based BGI Genomics, which went public with an $80 million IPO in July 2017.

Though its research business has shrunk in recent years following large investments in basic science and population-scale sequencing capacity, BGI has looked to shift its focus toward reproductive health screening and biomedical testing.

Illumina’s MiSeqDx system has previously received regulatory approvals in the U.S., Canada, Argentina, Australia, South Korea, Singapore, Thailand and the Philippines, as well as European countries recognizing the CE-IVD mark.

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