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Berry, Illumina Co-Develop NGS System for CFDA Review and Approval

Published: Monday, July 21, 2014
Last Updated: Monday, July 21, 2014
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Berry Genomics will use Illumina’s NGS technology to secure Chinese Food and Drug Administration regulatory approval for clinical applications, 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' BambniTM assay, which includes a library preparation kit, analysis software, and a sequencing instrument based on Illumina's NextSeqTM 500 Sequencing System. Berry's proprietary BambniTM assay, which has been validated on more than 200,000 samples, utilizes a unique PCR-free library prep technology and the proprietary RUPATM 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." 


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