Chinese Firm Enters Next-Generation Sequencing Market

Direct Genomics, a three-year-old Chinese firm, is taking on Illumina and other instrumentation market leaders with a next-generation sequencing (NGS) system designed for clinical diagnostics. Three Chinese hospitals are part of an early-access program using the company’s GenoCare Analyzer.

Although NGS is rapidly growing in the clinical testing area and equipment companies are improving the technology, the instruments remain “too complex for use by everyday physicians,” Goldman Sachs stock analyst Isaac Ro pointed out in a report earlier this month. “The notion of a sequencer in every hospital is not yet feasible and will require another leap in functionality.”

Direct Genomics’ system employs single-molecule targeted sequencing (SMTS) chemistry and total internal reflectance fluorescence microscopy to read DNA or RNA directly, according to Jiankui He, the firm’s founder and CEO. Unlike competing clinical systems, the GenoCare Analyzer does not require presequencing amplification.

The technology is a reboot of a sequencing-by-synthesis method developed a decade ago by Stephen Quake, then at Caltech and now at Stanford University. Quake’s firm, Helicos Biosciences, began building commercial-grade whole-genome sequencers around 2008 but was bankrupt by 2012. Helicos’s hardware assets reportedly were acquired by sequencing services provider SeqLL.

He, who is an associate professor at South University of Science & Technology of China, was a postdoc with Quake after completing his graduate work in the lab of Rice University’s Michael Deem. Both Quake and Deem, as well as former Helicos chief technology officer J. William Efcavitch, are Direct Genomics advisers. Backed by Chinese investors, the firm licensed key SMTS patents from Caltech this year.

The new system is much smaller and less expensive than the Helicos one, He says. Direct Genomics also continues to improve the chemistry and has published initial data on BioRxiv.org (2015, DOI: 10.1101/029686).

With about 1.4 billion people, China represents huge opportunity, and Direct Genomics is seeking Chinese FDA approval. Chinese service provider Berry Genomics has already received CFDA clearance for using a system developed with Illumina.