Propelled by NIPT, China Moves to the Fore in NGS Assays

Propelled by NIPT, China Moves to the Fore in NGS Assays

China is playing an increasingly significant role not only in the IVD industry, but global clinical markets. Kalorama Information offers comprehensive subject reports that variously treat the Chinese IVD, global cancer diagnostics, prenatal testing, circulating tumor cells (CTCs), and next-generation sequencing (NGS) markets.

The stakes are high for clinical next-generation sequencing (NGS) platform vendors in the Chinese market. In 2014, the Chinese Food & Drug Administration (CFDA; SFDA) and National Health and Family Planning Committee (NHFPC) mandated CFDA approval for NGS-based assays, primarily used in the booming domestic market for non-invasive prenatal tests (NIPTs). Regulators also established hospital pilot sites for the development and assessment of additional NGS-based assays prior to CFDA approval. The formalization of the clinical NGS market in China may restrict market entry and perhaps more broad-based industry innovation, but should help nurture more stable and diversified demand for clinical NGS assays such as in oncology. One market leader in the Chinese clinical NGS market, Illumina, characterized the opportunity availablefor its CDFA-approved, Berry Genomics-co-developed NextSeq CN500 instrument thusly:

“[We’d] say in general the diagnostic opportunities come to market earlier here and in places like China. So in NIPT and reproductive health China is a very large market opportunity. There’s 20 million babies born in China every year and some of the partners we’re working with over there think that in five years 10 million of them will be screened, non-invasively using a pre-natal test like ours, so huge, absolutely huge market opportunity.”

Including other CFDA-approved NGS platforms for NIPT such as BGI’s BGISEQ-100 and -1000, DaAn’s DA8600 (Life Technologies instrument), CapitalBio’s BioelectronSeq 4000 (Life Tech) and HYK Gene’s HYK-PSTAR-IIA, a clinical NGS instrument base has developed among Chinese urban hospitals. Kalorama Information estimates that China overall is home to nearly 10% of the world’s NGS systems.

Update: On September 30, 2015, Illumina and Amoy Diagnostics announced a partnership for the development of NGS-based oncology assays in the Chinese market

NGS-based cancer testing may in the future leverage the clinical instrument base developed for the NIPT market, but for now is limited to pilot sites associated with domestic NGS leaders. Beijing Genome Institute (BGI) offers two oncology tests: the 500-gene TumorCare panel analyzed from circulating tumor cells for treatment decisions and the Oseq/Sentis test for 21 genes related to hereditary ovarian and breast cancers. The CFDA NGS pilot program will be integral to BGI to expand assay claims and capabilities, including early cancer detection with the TumorCare panel. Other NGS pilot participants include Berry Genomics and Novogene. Berry Genomics may use the domestic NGS pilot program in conjunction with its current trials to introduce circulating tumor DNA (ctDNA) assays for lung cancer (EGFR gene) and gastrointestinal cancer (CKIT gene). The company is already a leader in the domestic NIPT market through its NextSeq CN500 instrument and NIPT kit. Novogene submitted two NGS cancer panels to the CFDA for approval in September 2015.

China is already home to an estimated 8% of all laboratories worldwide providing clinical genetic testing services; 9% of all NGS systems used in research or applied testing; and 5% of global revenue from cancer testing services. Despite slackened economic growth, the country remains a source of tremendous demand for clinical innovation and higher standards of care. Outside of North America, Europe and Japan, China is primed to emerge as the leading market for clinical NGS and molecular cancer testing.