Home Berry Genomics and BioNano Genomics Jointly Develop Next-Generation Chromosomal Structural Variant Analysis Platform

Berry Genomics and BioNano Genomics Jointly Develop Next-Generation Chromosomal Structural Variant Analysis Platform

Aug 18, 2016 12:37 CST Updated 12:37
On August 17, 2016, Beijing Berry Genomics Biotechnology Co., Ltd. (hereinafter referred to as “Berry Genomics”) and U.S.-based BioNano Genomics, Inc. (hereinafter referred to as “BioNano”) announced the joint development of next-generation clinical products for chromosomal structural variation analysis based on the Irys® platform. Meanwhile, Berry Genomics will submit product registration applications to the China Food and Drug Administration (CFDA).


Berry Genomics Has Partnered with Illumina


Berry Genomics was established in May 2010 as a cutting-edge biotechnology company dedicated to applying high-throughput gene sequencing technologies to provide “non-invasive” comprehensive solutions for clinical disease screening and diagnosis. Headquartered in Beijing, Berry Genomics operates clinical laboratories in Shanghai, Qingdao, Chengdu, Changsha, and Hangzhou, and has established a production base in Hangzhou. In September 2011, the company secured several million US dollars in Series A financing from Legend Capital. In September 2013, it raised $25 million in Series B financing from Legend Capital and Qiming Venture Partners.


Berry Genomics’ product portfolio includes the ABI 3130XL first-generation sequencing platform; second-generation sequencing platforms such as HiSeq 2500, MiSeq, and NextSeq CN500; the PacBio Sequel third-generation sequencing platform; as well as multi-domain, multi-application genetic testing platforms including Array CGH microarray, MassARRAY mass spectrometry, and Bio-Rad QX200 digital PCR. These offerings enable multi-tiered genetic disease detection covering chromosomal aneuploidy, chromosomal microdeletions and microduplications, and monogenic disorders. Furthermore, Berry Genomics’ technologies extend to oncology testing across multiple applications, including targeted therapy guidance, dynamic efficacy monitoring, and comprehensive personalized tumor profiling.


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Berry Genomics Business Ecosystem Diagram


According to VCBeat (WeChat ID: vcbeat), Berry Genomics received certification as a Zhongguancun High-Tech Enterprise in the same month it secured its Series A financing. In December 2012, the company was certified as a National High-Tech Enterprise. In May 2014, Berry Genomics partnered with Illumina to develop a sequencer tailored to the demands of China’s non-invasive prenatal testing (NIPT) market. This sequencer is manufactured at Berry Genomics’ own medical equipment production facility in China and is sold exclusively in the Chinese market.


BioNano Genomics Focuses on Gene Imaging and Analysis Technology


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BioNano Genomics, founded in 2003, is a company focused on genomic imaging and analysis technologies. Its technology enables structural analysis at the level of genes and their associated peptides and proteins. BioNano Genomics is dedicated to providing customers with genomic analysis tools to advance human, plant, and animal genomics research and accelerate the development of clinical diagnostic technologies. The company’s Irys® System leverages NanoChannel® technology, a leader in the genomics industry, to perform single-molecule imaging of molecules with an average sequence length of 350,000 base pairs using the IrysChip®. By obtaining long-range genomic information through the Irys® System, it helps decipher complex DNA repetitive sequences, addressing a major challenge that leads to inaccurate and incomplete genome assemblies.


Viewpoint: Clinical Demand for Chromosomal Structural Variation Detection in China Is Surging


Under the terms of this collaboration agreement, both parties will jointly develop a next-generation analysis system for detecting chromosomal structural variants that features high throughput, high resolution, and ease of use.


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Diagram of Chromosomal Structural Variations and Their Effects


VCBeat (WeChat ID: vcbeat) has learned that the system will consist of devices and test kits based on the Irys® platform, jointly developed by Berry Genomics and BioNano. For specific clinical application areas, Berry Genomics holds exclusive rights to manufacture and market the system in China. In the field of scientific research, BioNano sells its research-use Irys® system to Chinese research institutions, including genomics research centers, government agencies, academic institutions, translational research organizations, and pharmaceutical companies.


Dr. Zhou Daixing, CEO of Berry Genomics, stated that in China, the clinical demand for detecting chromosomal structural variants is growing rapidly. Existing detection methods, such as karyotyping, fluorescence in situ hybridization (FISH), and microarray technology, have limitations including long experimental turnaround times and extensive manual labor requirements, and they typically fail to provide comprehensive detection of genetic variants. Dr. Zhou remarked, “We believe the Irys® platform is the most suitable solution. Products based on this platform will address the shortcomings of existing technologies. As the industry leader in next-generation chromosomal structural variant analysis, BioNano is undoubtedly our ideal partner. It is the only company globally that possesses high-resolution detection technology capable of systematically and comprehensively analyzing chromosomal structural variants. Currently, existing technologies, including high-throughput sequencing, have yet to achieve comprehensive detection of pathogenic structural variants in the human genome.”


Dr. Erik Holmlin, CEO of BioNano Genomics, stated, “Through innovative product models, Berry Genomics has become a leader in China’s non-invasive prenatal testing (NIPT) market. We hope that our next-generation platform for chromosomal structural variation analysis will help Berry Genomics achieve similar leadership across broader fields, including genetic diseases and oncology. By collaborating with leading global clinical diagnostics companies, we aim to elevate human disease diagnosis to new heights through Irys® technology. This partnership with Berry Genomics serves as a prime example of this effort.”