News Column

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

August 4, 2014

By a News Reporter-Staff News Editor at Biotech Business Week -- Berry Genomics Co. Ltd. announced 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 (see also Biotechnology Companies).

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.

Keywords for this news article include: Asia, China, Illumina, Software, Biotechnology Companies.

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Source: Biotech Business Week

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