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China's FDA Grants Premarket Clearance to Berry Genomics NextSeq CN500 Instrument, Prenatal Testing Kit
31 March 2015 - - Chinese biotech company Berry Genomics Co. Ltd.'s Hangzhou Berry Genomics subsidiary has received premarket clearance from the Chinese Food and Drug Administration for its NextSeq CN500 high throughput sequencing instrument, the company said on Tuesday. NextSeq CN500 was developed by Berry Genomics with Illumina (NASDAQ: ILMN). Hangzhou Berry Genomics also received premarket clearance for its non-invasive prenatal testing detection kit for trisomies 13, 18 and 21. The NextSeq CN500 utilises 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. Berry Genomics develops and commercialises sequencing-based integrated solutions for clinical applications, primarily in genetic testing and oncology testing.
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