Berry Genomics and Illumina Co-Develop Integrated Next-Generation Sequencing System for Review and Approval by Chinese

  Berry Genomics and Illumina Co-Develop Integrated Next-Generation Sequencing
  System for Review and Approval by Chinese Regulatory Agency

Business Wire

BEIJING & SAN DIEGO -- July 21, 2014

Berry Genomics Co. Ltd. announced today it has chosen Illumina Inc’s. (NASDAQ:
ILMN) next-generation sequencing (NGS) technology as the platform on which
Berry will secure Chinese Food and Drug Administration (CFDA) regulatory
approval for clinical applications, thereby expanding access to NGS-based
tests in China.

Under the agreement, the companies co-developed an NGS system to provide a
cost-effective, easy-to-use assay for non-invasive prenatal testing (NIPT). A
working version of the new assay and instrument system has been validated in
clinical settings in China, and is in late stage review under the CFDA’s
medical device registration process.

The new system integrates Berry Genomics’ Bambni™ assay, which includes a
library preparation kit, analysis software, and a sequencing instrument based
on Illumina’s NextSeq™ 500 Sequencing System. Berry’s proprietary Bambni™
assay, which has been validated on more than 200,000 samples, utilizes a
unique PCR-free library prep technology and the proprietary RUPA™ analysis

“There are two million high-risk and advanced maternal age pregnancies a year
in China, which is about three times the size of the U.S. market. We need to
ensure we are addressing women’s needs by offering a safe and proven
technology. As the first and only company with a U.S. FDA cleared
next-generation sequencing instrument, Illumina is an ideal collaboration
partner given their experience,” said Daixing Zhou, CEO of Berry Genomics.

“Berry is one of the leading providers of NIPT in China, and Illumina is
excited to collaborate with them to customize the NextSeq under CFDA
requirements,” said Greg Heath, Senior Vice President, IVD Development at
Illumina. “This agreement is an example of our commitment to working with
clinical companies in China and worldwide who want to develop and
commercialize in vitro diagnostics based on next-generation sequencing.”

About Berry Genomics

Berry Genomics ( 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 a leading developer, manufacturer, and marketer
of life science tools and integrated systems for the analysis of genetic
variation and function. We provide innovative sequencing and array-based
solutions for genotyping, copy number variation analysis, methylation studies,
gene expression profiling, and low-multiplex analysis of DNA, RNA, and
protein. We also provide tools and services that are fueling advances in
consumer genomics and diagnostics. Illumina’s technology and products
accelerate genetic analysis research and its application, paving the way for
molecular medicine and ultimately transforming healthcare.

Forward-Looking Statement for Illumina

This release may contain forward looking statements that involve risks and
uncertainties. Important factors that could cause actual results to differ
materially from those in any forward-looking statements are detailed in our
filings with theSecurities and Exchange Commission, including our most recent
filings on Forms 10-K and 10-Q, or in information disclosed in public
conference calls, the date and time of which are released beforehand. We do
not intend to update any forward-looking statements after the date of this


Jingjing Zhao, +86 10 84403068
Rebecca Chambers, 858-255-5243
Jennifer Temple, 858-882-6822
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