This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

QIAGEN Announces Partnership With Clovis Oncology To Co-develop Companion Diagnostic Targeting Drug-Resistant EGFR Mutations

Stocks in this article: CLVSQGEN

GERMANTOWN, Maryland, and HILDEN, Germany, October 21, 2013 /PRNewswire/ --

  • Collaboration to expand label of QIAGEN's FDA-approved  therascreen ®   EGFR RGQ PCR Kit and creates framework for long term development and commercialization partnership
  • Companion diagnostic will run on QIAGEN's efficient Rotor-Gene Q MDx platform
  • QIAGEN adds to growing portfolio of companion diagnostics in co-development with world's leading pharmaceutical and biotechnology companies

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced a partnership with Clovis Oncology (NASDAQ: CLVS) to co-develop and co-commercialize a companion diagnostic test to guide the use of CO-1686, a novel Clovis Oncology product candidate currently in clinical development. The Clovis drug candidate will initially target an unmet clinical need in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for whom current EGFR-inhibiting drugs no longer control disease.

The diagnostic will build on QIAGEN's therascreen ® EGFR RGQ PCR Kit, which was approved by the U.S. Food and Drug Administration (FDA) in July 2013 as a companion diagnostic for use in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Analytical performance of the therascreen  EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of the QIAsymphony family of laboratory solutions.

The development plan for the companion diagnostic complements Clovis Oncology's accelerated plan for CO-1686 development by potentially allowing a supplemental premarket approval (PMA) filing for the diagnostic. Subject to regulatory approvals, QIAGEN will be responsible for the global development and commercialization of the companion diagnostic, and Clovis will be responsible for the global development and commercialization of CO-1686. The partners also created the framework for possible future collaborations, thereby adding another master agreement to QIAGEN's growing pipeline of collaborations with some of the world's leading pharmaceutical and biotechnology companies. Further terms of the agreement were not disclosed.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,805.41 +127.51 0.76%
S&P 500 1,964.58 +13.76 0.71%
NASDAQ 4,483.7150 +30.9230 0.69%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs