Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

WILEX Inc. and GeneDiagnostics Inc. Partner to Commercialize Serum HER-2/neu Test in China

Published: Wednesday, January 23, 2013
Last Updated: Wednesday, January 23, 2013
Bookmark and Share
Test already approved in US, now seeking IVD clearance.

WILEX AG announced that its US subsidiary WILEX Inc., Cambridge, MA, has entered into an exclusive distribution agreement with GeneDiagnostics Inc. for the commercialization of the serum HER-2/neu ELISA test in China. This biomarker test is FDA cleared in the USA, carries the CE mark for the European market, and is currently for Research Use Only in the Chinese market. GeneDiagnostics plans to conduct clinical studies in leading hospitals in China for the IVD clearance through the State Food and Drug Administration in China (SFDA) as part of the terms. GeneDiagnostics is a clinical research and service provider based in Hangzhou, China, and has well-established business relationships with major hospitals. Financial terms of the agreement were not disclosed.

Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, comments: “The Chinese market is expected to be one of the fastest growing pharma markets in the world. Therefore, we are pleased to have in GeneDiagnostics a competent partner to pursue an IVD approval for our serum HER-2/neu test as well as to distribute the test in this key market.”

“According to the latest statistics from the Chinese Ministry of Health 126,000 new cases of breast cancer were reported each year. This corresponds to roughly one-tenth of the world’s total and is expected to increase by at least 4 percent annually. We look forward to introducing this HER-2/neu ELISA test into the Chinese market as we believe that it can help physicians administer targeted treatments to carefully diagnosed patients with metastatic breast cancer”, said Dr Mark Han, President and Chief Scientist of GeneDiagnostics Inc.


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 2,900+ scientific posters on ePosters
  • More Than 4,200+ 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.


Scientific News
Head Injury Patients have Protein Clumps Associated with Alzheimer’s Disease
Scientists have revealed that protein clumps associated with Alzheimer's disease are also found in the brains of people who have had a head injury.
Exposure to Air Pollution 30 Years Ago Associated with Increased Risk of Death
Exposure to air pollution more than 30 years ago may still affect an individual's mortality risk today, according to new research from Imperial College London.
More Then 1 in 20 U.S. Children have Dizziness and Balance Problems
Researchers at NIH have found that girls have a higher prevalence of dizziness and balance problems compared to boys, 5.7 percent and 5.0 percent.
Biosensors on Demand
New strategy results in custom "designer proteins" for sensing a variety of molecules.
Low-Cost, Portable NQR Spectroscopy
A researcher at Case Western Reserve University is developing a low-cost, portable prototype designed to detect tainted medicines and food supplements that otherwise can make their way to consumers. The technology can authenticate good medicines and supplements.
Structure of Brain Plaques in Huntington's
Researchers at the University of Pittsburgh School of Medicine have shown that the core of the protein clumps found in the brains of people with Huntington's disease have a distinctive structure, a finding that could shed light on the molecular mechanisms underlying the neurodegenerative disorder.
Insights into the Function of the Main Class of Drug Targets
About thirty percent of all medical drugs such as beta-blockers or antidepressants interact with certain types of cell surface proteins called G protein coupled receptors.
Spero Therapeutics Announces $30 Million Series B Preferred Financing
Company has announced financing of $30 million to support development of novel therapies to treat gram-negative bacterial infections.
Unique Mechanism for a High-Risk Leukemia
Researchers uncovered the aberrant mechanism underlying a notoriously treatment-resistant acute lymphoblastic leukemia subtype; findings offer lessons for understanding all cancers.
Visualizing a Cancer Drug Target at Atomic Resolution
Using cryo-electron microscopy, researchers were able to view, in atomic detail, the binding of a potential small molecule drug to a key protein in cancer cells.
Scroll Up
Scroll Down
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!