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 software.
“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 ( 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 ( www.illumina.com) 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 the Securities 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 release.
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