Illumina gets green light for next-generation sequencers in China

The China National Drug Administration has approved for the first time a second-generation DNA sequencer produced by sequencing giant Illumina. The news comes as China becomes a strategically important, but tough, market for Illumina and other foreign producers of genome sequencers.

The CNDA-approved device is a MiSeqDx, a type of instrument that Illumina first cleared for market launch in the U.S. in 2013. Its next-generation sequencing (NGS) capabilities mean that it conducts high-throughput DNA and RNA screenings much more quickly and cheaply than earlier types of sequencers.

The firm will primarily market the system to clinical laboratories that conduct patient diagnostic tests. Saluting the news, Garret Hampton, Illumina’s executive vice president of clinical genomics, said that “more medical institutions and patients will now have access to the latest NGS technology.”

The Chinese market has been growing in importance for Illumina and is now its second largest after the U.S. In its results for the fiscal year that ended December 2017, Illumina started disclosing its sales in China because of their material importance to the firm. At $292 million last year, Chinese sales exceed those in the rest of Asia combined, including Japan. Illumina had U.S. sales of over $1.5 billion in 2017.

However, the U.S. firm faces fierce competition in China. The country is the home of Shenzhen-based BGI, the world’s largest producer of sequencers. BGI has a head start on Illumina, having launched its NGS devices in China more than two years ago. And Oxford Nanopore Technologies, one of Illumina’s main global competitors, launched several of its sequencers in China last October, though none with NGS capabilities.

Illumina has made efforts to bolster its profile in China. In March, for instance, it launched a program with the Chinese Medical Doctor Association to offer genome sequencing to Chinese children with birth defects or undiagnosed diseases. Low-income families will have access to the tests.