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China FDA Approves BGI NGS Assays Based on Ion Torrent and Complete Genomics NGS Technology

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This story was originally published on July 8.

NEW YORK (GenomeWeb) – Earlier this month, the China Food and Drug Administration said it approved two next-generation sequencing-based diagnostic products developed by BGI — the first NGS assays to receive CFDA approval.

BGI told Clinical Sequencing News that the two sequencing systems — BGISEQ-100 and BGISEQ-1000 — are based on Thermo Fisher's Ion Torrent semiconductor sequencing technology and Complete Genomics' sequencing technology, respectively.

The NGS systems have been approved in conjunction with BGI's noninvasive prenatal diagnostic kit, marketed as NIFTY, which screens for fetal aneuploidies in chromosomes 21, 18, and 13.

BGI suspended clinical testing with NIFTY in March following an announcement from the CFDA that genetic testing should be regulated. At the time, BGI said it would work with the CFDA to gain approval of NGS-based diagnostic tests.

Now, with NIFTY approved on BGISEQ-100 and BGISEQ-1000, BGI told CSN that it would continue to work with the CFDA to gain approval for other NGS-based tests.

"The genomics technology has been proved as an advanced approach for detecting birth defects and monogenetic diseases," said Bicheng Yang, BGI's director of communications and public engagement. "BGI will continue to work on developing genetic tests for the ultimate goal of preventing birth defects," she added.

The BGISEQ-100 system is based on Ion Torrent semiconductor sequencing. Although the instrument is similar to and uses the same chemistry as the Proton, it is manufactured by BGI, not Thermo Fisher, according to a Thermo Fisher spokesperson.

The deal is different than the one Thermo Fisher has with diagnostic firm VelaDx. In that case, Thermo Fisher still manufactures the instrument, but it is configured for VelaDx's diagnostic assays.

BGI has established its own "technical platforms based on a variety of large-scale sequencing technologies, bioinformatics expertise, and systematic analysis," Yang said.

She did not disclose whether BGI was also developing diagnostic products based on Illumina's sequencing technology — BGI operates over 100 Illumina NGS systems — but said that BGI is "open-minded to develop different applications, applying the most suitable technologies and solutions."

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