Berry Genomics NextSeq CN500 Instrument and Non-Invasive Prenatal Testing Reagent Kit Receives Chinese FDA Premarket Clearance
March 31 2015 - 8:19AM
Business Wire
Products Collaboratively Developed by Berry
Genomics and Illumina Serve Chinese Clinical NIPT Market
Berry Genomics Co., Ltd. announced today 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 (NASDAQ:ILMN) 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. “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.”
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, visit
www.illumina.com and follow @illumina.
Berry Genomics Co., Ltd.Media:Jingjing Zhao+86 10
84403068zhaojingjing@berrygenomics.comorIllumina,
Inc.Investors:Rebecca
Chambers858-255-5243rchambers@illumina.comorMedia:Jennifer
Temple858-882-6822pr@illumina.com
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