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

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 3,200+ scientific posters on ePosters
  • More than 4,600+ 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

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 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
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 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
Almac Group, Illumina Collaborate
Almac Diagnostics today announced that it had entered into a collaboration with Illumina, Inc. to establish a framework for the development of next-generation sequencing (NGS)-based companion diagnostic assays.
Friday, November 13, 2015
Amoy Diagnostics and Illumina Enter Strategic Collaboration
Collaboration for next-generation sequencing cancer diagnostics in China.
Thursday, October 01, 2015
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
Scientific News
Proteins in Blood of Heart Disease Patients May Predict Adverse Events
Nine-protein test shown superior to conventional assessments of risk.
£14m EU Project To Aid Meningitis Diagnosis and Cut Antibiotic Use
An international team of doctors are aiming to develop a rapid test to allow medics to quickly identify bacterial infection in children.
Bringing AFM to Medical Diagnostics
Company has announced that its NanoWizard® AFM and ForceRobot® systems are being used in the field of medical diagnostics in the Supersensitive Molecular Layer Laboratory of POSTECH in Korea.
Scientific Gains May Make Electronic Nose the Next Everyday Device
UT Dallas team breathes new life into possibilities by using CMOS integrated circuits technology.
Electronic Sensor Tells Dead Bacteria From Live
The sensor, which measures 'osmoregulation', is a potential future tool for medicine and food safety.
Diagnosing Systemic Infections Quickly, Reliably
Team develop rapid and specific diagnostic assay that could help physicians decide within an hour whether a patient has a systemic infection and should be hospitalized for aggressive intervention therapy.
A Future Tool for Medicine, Food Safety
A new type of electronic sensor that might be used to quickly detect and classify bacteria for medical diagnostics and food safety has passed a key hurdle by distinguishing between dead and living bacteria cells.
Genome Sequencing Helps Determine End of TB Outbreak
Using genome sequencing, researchers from the University of British Columbia, along with colleagues at the Imperial College in London, now have the ability to determine when a tuberculosis (TB) outbreak is over.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Shimmer Partners with Harvard's Wyss Institute
Partnership to support ongoing research focused on remote patient monitoring using wearable sensing technology.
SELECTBIO

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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!