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Berry Genomics Lands China FDA Approval for NIPT Sequencer

NEW YORK (GenomeWeb) – Hangzhou Berry Genomics has received premarket clearance from the Chinese Food and Drug Administration for its NextSeq CN500, a high-throughput sequencing instrument for non-invasive prenatal testing, and its NIPT kit, according to Berry partner Illumina.

The NextSeq CN500 offers Illumina's next-generation sequencing technology and was designed to be used in Chinese clinical settings. It can process up to 96 samples per run. Hangzhou Berry Genomics' NIPT kit was designed to be complementary to Illumina's technology and uses a proprietary PCR-free protocol, which allows the test to be run in a single tube.

Hangzhou Berry Genomics, a subsidiary of Berry Genomics, also received premarket clearance for its NIPT kit for detecting trisomies 13, 18, and 21.

"From original conception in 2007 to its current IVD products, NIPT has gone through an adoption process with unprecedented speed," Berry Genomics CEO Daixing Zhou said in a statement. "By being able to partner with Illumina to develop and deliver an instrument that is suitable for Chinese clinical laboratories, we hope to serve the Chinese population with the most advanced technologies available in the world."

In July 2014 the Chinese FDA approved next-generation sequencing products from BGI, including the BGISEQ-100, which is based on Thermo Fisher Scientific's Ion Torrent sequencing technology, and the BGISEQ-1000, an instrument based on Complete Genomics' sequencing technology, as well as diagnostic kits for fetal chromosomal aneuploidy that screen for trisomies 13, 18, and 21.