Corporate Banner
Satellite Banner
Next Gen Sequencing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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

Published: Monday, July 21, 2014
Last Updated: Monday, July 21, 2014
Bookmark and Share
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." 


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,100+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Illumina Registers MiSeqDx System in South Korea
Regulatory milestone clears path for clinical laboratories to use Illumina NGS technology.
Tuesday, May 10, 2016
Illumina Files Patent Infringement Suit against Genoma SA
Company has announced that it has filed a patent infringement suit against Genoma SA in the Switzerland for Infringement of NIPT Patents.
Friday, April 22, 2016
Illumina Invests In New Venture Fund
Illumina will commit $100M over 10 years to drive genomic technology development.
Friday, April 15, 2016
Illumina Applies CE Mark to VeriSeq™ NIPT Analysis Software
Company has announced that it has applied the CE mark to expand the use of VeriSeq NIPT analysis software in clinical laboratories.
Thursday, February 25, 2016
Illumina Sues Oxford Nanopore for Patent Infringement
Illumina, Inc. has announced that the company filed lawsuits against Oxford Nanopore Technologies Ltd. and Oxford Nanopore Technologies, Inc. (ONT).
Wednesday, February 24, 2016
Genomics England, Illumina Enter Bioinformatics Partnership
Illumina, and Genomics England have announced a partnership to develop a platform and knowledge base that can be used to improve and automate genome interpretation.
Thursday, February 11, 2016
Illumina Signs Multiple Biobank Deals
MEGA array family and next-generation sequencing to support comprehensive genomics approach toward personalized medicine.
Wednesday, February 03, 2016
Illumina Appoints Dr. Frances Arnold to Its Board of Directors
Illumina, Inc. has announced that Dr. Frances Arnold has joined the company’s Board of Directors. Dr. Arnold manages a research group at the California Institute of Technology and is the Director of the Donna and Benjamin M. Rosen Bioengineering Center.
Thursday, January 28, 2016
Illumina Acquires Conexio Genomics
Acquisition strengthens company’s ability to deliver sample-to-report solutions for HLA typing.
Wednesday, January 27, 2016
Bio-Rad, Illumina Partner
Scalable, high-throughput platform to offer unprecedented insight into gene expression of individual cells.
Tuesday, January 12, 2016
Illumina Launches Cancer Screening Company
Formation of GRAIL seen as a significant development in the war on cancer.
Monday, January 11, 2016
Novogene and Illumina Enters into Agreement
Agreement to co-develop NGS diagnostic system for reproductive health and oncology applications.
Wednesday, December 16, 2015
bioMérieux and Illumina Announce the Launch of bioMérieux EpiSeq™
A revolutionary next-generation sequencing service for epidemiological monitoring of bacterial infections.
Tuesday, December 15, 2015
Illumina Accelerator Announces Third Funding Cycle of Genomics Startups
Invests in synthetic biology, reproductive health, skin microbiome and nutrition startups.
Thursday, December 10, 2015
Desktop Genetics Receives Strategic Investment from Illumina
Illumina invests in Desktop Genetics' technology to support the platform's integration with NGS pipelines and improve CRISPR genome editing workflows.
Thursday, December 10, 2015
Scientific News
How Did The Giraffe Get Its Long Neck?
Clues about the evolution of the giraffe’s long neck have now been revealed by new genome sequencing.
Big Data Can Save Lives
The sharing of genetic information from millions of cancer patients around the world could be key to revolutionising cancer prevention and care, according to a leading cancer expert from Queen's University Belfast.
Making Genetic Data Easier to Search
Scripps team streamlines biomedical research by making genetic data easier to search.
Collaborative Study of WES Offers New Hope
Company has announced that the collaborative study of whole exome sequencing offers new hope for children with white matter disorders.
Using Portable Nanopore DNA Sequencers to Combat Wildlife Crime
University of Leicester researchers aim to develop a test using DNA to identify species at crime scenes in as little as an hour.
TGAC Installs Largest SGI UV 300 Supercomputer for Life Sciences
The Genome Analysis Centre (TGAC) partners with Global HPC hardware giant SGI to address the most complex problems in genomics analysis.
Shining A Light On Bladder Cancer
Researchers scrutinize patterns of mutations in bladder tumor genomes, gleaning insights into the roles of DNA repair and tobacco-related DNA damage.
Monovar Drills Down Into Cancer Genome
Rice, MD Anderson develop program to ID mutations in single cancer cells.
Five New Breast Cancer Genes Found
Discovery of mutations paves the way for personalised treatment of breast cancer.
New Neurodevelopmental Syndrome Identified
Study pinpoints underlying genetic mutations, raising hopes for targeted therapies.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!