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

Amgen and Illumina Enter Agreement

Published: Monday, January 20, 2014
Last Updated: Monday, January 20, 2014
Bookmark and Share
Illumina to develop IVD kit on its FDA-cleared MiSeqDx™ NGS instrument for Amgen’s Vectibix (Panitumumab).

Illumina, Inc. has announced that it has entered into an agreement with Amgen Inc. to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the US and EU.

Under the terms of the collaboration, premarket approval of the test by the US Food and Drug Administration (FDA) and other regulatory bodies will be sought.

The test will be developed for use with Illumina's MiSeqDx™ instrument, which received premarket clearance from the FDA on November 19, 2013 and was CE-marked for the European Union on July 16, 2013.

The collaboration will seek to validate a test platform that can identify RAS mutation status of patients who would be appropriate to receive Vectibix. Following CE marking and FDA approval, Illumina plans to commercialize the test with a focus on US and EU markets. This collaboration also demonstrates Illumina’s commitment to partnering with therapeutics companies and to bringing its leading NGS technologies into oncology care.

“This collaboration is consistent with our strategy to bring the power of NGS to clinical diagnostics,” said Nick Naclerio, Senior Vice President of Corporate and Venture Development and General Manager of Illumina’s Enterprise Informatics business at Illumina. “With three FDA-cleared NGS products in our portfolio, we intend to complement internal development programs by taking products developed with external partners through the FDA submission process. Amgen is a key partner given their leadership in therapeutic development and strong track record in commercializing novel products.”

Dr. Rick Klausner, Chief Medical Officer and acting General Manager of Illumina’s Oncology business, added, “NGS provides an advantage over traditional technologies that typically detect only one or a few variants. Multigene NGS panels provide a more complete genetic picture of each patient’s tumor, which can better inform critical treatment decisions. We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes.”


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 3,900+ scientific posters on ePosters
  • More than 5,300+ 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 Accelerator Welcomes First International Fellow
Illumina Accelerator has expanded their startup pool with the Center of Individualized Diagnostics (CID).
Wednesday, August 24, 2016
Illumina Applauds FDA’s Issuance of Draft Guidances
Company has supported the FDA in their efforts to provide a flexible and streamlined approach to the oversight of NGS diagnostic test.
Friday, July 08, 2016
ArcherDX, Illumina Launch Collaboration
Agreement to bring multiple Archer® assays through the FDA approval process.
Tuesday, May 31, 2016
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
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
Accelerating the Detection of Foodborne Bacterial Outbreaks
The speed of diagnosis of foodborne bacterial outbreaks could be improved by a new technique developed by researchers at the Georgia Institute of Technology.
Antibiotics Discovered While Sifting Through Human Microbiome
Researchers identify genes in a microbe’s genome that produce antibiotic compounds, then synthesize them without the need for bacterial culture.
A Genome-wide View of Human DNA Viruses
In this study, Duplex sequencing was used to accurately analyse the genome-wide rate of spontaneous mutation of human adenovirus C5 (HAdv5).
Peer Review is in Crisis, But Should be Fixed, Not Abolished
After the time to get the science done, peer review has become the slowest step in the process of sharing studies, and some scientists have had enough.
Rare Immunodeficiency Yields Unexpected Insights
Scientists uncover previously unknown gene mutation revealing the role of a key molecule involved in immune cell development.
Illumina Contributes to ClinVar Database
The contribution includes variants of all classifications, from pathogenic to benign, identified during interpretation of whole genome sequences generated in the CLIA-certified, CAP-accredited Illumina Clinical Services Laboratory.
Agilent Presents Early Career Professor Award to Dr. Roeland Verhaak
JAX professor recognized for the development and implementation of workflows for the analysis of big-data from transcriptomics to next generation sequencing approaches.
Integrated Omics Analysis
Studying multi-omics promises to give a more holistic picture of the organism and its place in its ecosystem, however despite the complexities involved those within the field are optimistic.
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
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!