• Berry Genomics’ NextSeq CN500 Instrument and Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance
  • Apr 01,2015


    Products Collaboratively Developed by Berry Genomics and Illumina Serve Chinese Clinical NIPT Market

    Beijing and San Diego—March 31, 2015—Berry Genomics Co., Ltd. announced today that Hangzhou Berry Genomics, a subsidiary of Berry Genomics, 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 the premarket clearance for its non-invasive prenatal detection (NIPT) kit for trisomy 13/18/21.

    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 reactions to a two-step workflow in a single tube.

    “From the 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. “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 CFDA,” said Tristan Orpin, Senior Vice President & General Manager, Reproductive and Genetic Health of Illumina. “We value the relationship with Berry Genomics, which is 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 most advanced sequencing-based clinical applications available on the market.”

    About Berry Genomics

    Berry Genomics (www.berrygenomics.com) is a leading biotech company in China which develops and commercializes next generation sequencing based integrated solutions for clinical applications, primarily in genetic testing and oncology testing. Berry Genomics pioneered non-invasive prenatal testing (NIPT) in China and is the leading provider of NIPT in China. Like NIPT, the products and technologies under development at Berry Genomics will address unmet needs of other genetic diseases and cancer.

    About Illumina

    Illumina is transforming human health as the global leader in sequencing and array-based technologies. The company serves customers in a broad range of markets, enabling the adoption of genomic solutions in research and clinical settings. To learn how Illumina is unlocking the power of the genome, visitwww.illumina.com and follow @illumina.


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