Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
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
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 2,500+ scientific posters on ePosters
  • More than 3,800+ 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

Burning Rock and Illumina Collaborate on Molecular Diagnostics for Oncology
Collaboration highlights the ever-increasing importance of genomics to improve healthcare in China.
Tuesday, August 25, 2015
Illumina Accelerator Invests in Second Class of Genomics Startups
Startups selected from Spain, Oregon, and California to advance breakthrough applications.
Thursday, August 06, 2015
Discordant NIPT Test Results May Reflect Presence of Maternal Cancer
Results published in Journal of the American Medical Association.
Tuesday, July 14, 2015
Annoroad and Illumina to Co-Develop NGS Diagnostic System
Both Companies have entered into an agreement to jointly develop advanced clinical applications for reproductive health.
Thursday, June 11, 2015
Illumina Files Patent Infringement Suit Against Premaitha
Patent infringement suit filed in the United Kingdom against Premaitha Health plc for infringement of NIPT patents.
Monday, March 16, 2015
Illumina Announces Strategic Collaboration with Merck Serono
Collaboration to expand companion diagnostics for oncology.
Friday, March 13, 2015
£15m Initiative Puts Scotland at Forefront of Gene-Led Healthcare
Initiative sees the Universities of Edinburgh and Glasgow partner with Illumina.
Monday, January 12, 2015
Illumina and Sequenom Enter Settlement
Illumina and Sequenom pool noninvasive prenatal testing intellectual property and end outstanding patent disputes.
Wednesday, December 03, 2014
USAID, Broad Institute and Illumina Form a Public-Private Partnership
Partnership aims to combat the Ebola epidemic in West Africa.
Wednesday, November 19, 2014
Illumina Announces Oncology CDx Partnership with AstraZeneca, Janssen and Sanofi
Illumina, forms collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing (NGS)-based oncology test system.
Thursday, August 21, 2014
Berry, Illumina Co-Develop NGS System for CFDA Review and Approval
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.
Monday, July 21, 2014
Illumina Acquires CDx Firm Myraqa
Illumina has acquired Myraqa, a regulatory and quality consulting firm specializing in IVDs, particularly companion diagnostics.
Wednesday, July 16, 2014
Illumina Appoints Senior VP of Oncology
Company names Tina S. Nova as Senior Vice President and General Manager of oncology.
Tuesday, July 15, 2014
Illumina Agreements to Expand Access for Non-Invasive Prenatal Testing Across Europe
Biomnis, Genoma, and the Center for Human Genetics and Laboratory Diagnostics Martinsried to use the HiSeq 2500 and consumables from Illumina to develop and perform non-invasive prenatal testing.
Monday, June 30, 2014
Illumina to Provide NGS Technologies to Quest Diagnostics
The multi-year licensing agreement is related to the use of Illumina's next-generation sequencing technology for clinical laboratory testing.
Thursday, January 09, 2014
Scientific News
‘Mutation-Tracking’ Blood Test for Breast Cancer
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.
Common ‘Heart Attack’ Blood Test May Predict Future Hypertension
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressure.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Signature of Microbiomes Linked to Schizophrenia
Studying microbiomes in throat may help identify causes and treatments of brain disorder.
Imaging Software Could Speed Breast Cancer Diagnosis
Technology could improve access to diagnostic services in developing countries.
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Data Mining DNA For Polycystic Ovary Syndrome Genes
A new Northwestern Medicine genome-wide association study of PCOS – the first of its kind to focus on women of European ancestry – has provided important new insights into the underlying biology of the disorder.
Algorithm Interprets Breathing Difficulties to Aid in Medical Care
Researchers from North Carolina State University have developed an efficient algorithm that can interpret the wheezing of patients with breathing difficulties to give medical providers information about what’s happening in the lungs.
Researchers Develop qPCR Prognosis Test for NSCLC Patients
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use of adjuvant therapy in patients struggling with the disease.
Skyscraper Banner

Skyscraper Banner
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!