Berry Genomics Co., Ltd. has announced that Hangzhou Berry Genomics, a subsidiary of Berry Genomics Co., Ltd., has received premarket clearance from the Chinese Food and Drug Administration (CFDA) for the NextSeq CN500, a high throughput sequencing instrument developed with Illumina to meet Chinese clinical needs.
Hangzhou Berry Genomics also received premarket clearance for its non-invasive prenatal testing (NIPT) detection kit for trisomies 13, 18 and 21.
The NextSeq CN500 utilizes Illumina’s sequencing by synthesis technology and was designed for operations in a clinical setting. Complementary with NextSeq CN500, Berry Genomics’ NIPT kit is based on a proprietary PCR-free protocol, which simplifies the complex NIPT sample preparation process to a two-step workflow in a single tube. The system can process up to 96 samples per instrument run.
“From original conception in 2007 to its current IVD products, NIPT has gone through an adoption process with unprecedented speed. Thanks to the tremendous support provided by the Chinese government and clinicians, China today is at the forefront of NIPT development,” said Daixing Zhou, Chief Executive Officer of Berry Genomics.
Zhou continued, “Illumina’s market-leading sequencing technology has earned its place as the gold standard in the industry. 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.”
“We are excited about the premarket clearance of the NextSeq CN500 by the CFDA,” said Tristan Orpin, Senior Vice President & General Manager, Reproductive and Genetic Health, of Illumina. “We value the relationship with Berry Genomics, a leader in NIPT in China, and are honored to make contributions to improve the health of the Chinese population. We will continue collaborating with Berry Genomics to deliver the gold standard in sequencing-based clinical applications to the market.”