BETHLEHEM, Pa., March 3, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) and Roche announced today that the U.S. Food and Drug Administration ("FDA") has granted the Companies 510(k) clearance on four homogeneous fully automated oral fluid drugs of abuse assays developed to be used exclusively as part of OraSure's Intercept ® Oral Fluid Drug Testing System. The cleared oral fluid assays include Phencyclidine (PCP), Cocaine, Opiates and Methamphetamine.
The oral fluid assays use Roche's KIMS (kinetic interaction of micro-particles in solution) technology and were jointly developed under an agreement previously signed by the parties. These assays are designed to run on various clinical chemistry automated analyzers, which are intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.
"We are very pleased to announce this significant milestone in our joint effort with Roche to develop and market these important drugs of abuse assays," said Douglas A. Michels, President and CEO of OraSure Technologies. "The combination of Roche's industry leadership in lab instrumentation and reagent chemistry and our leadership in oral fluid technology and sample collection devices has enabled us to bring to market a breakthrough system that will have an immediate and positive impact on laboratory efficiency for drugs of abuse testing.""The approval of this first set of fully automated oral fluid drugs of abuse assays demonstrates the strengths and experience of both companies," said Frank G. Sieben, SVP and Life Cycle Leader of Roche Professional Diagnostics. "Specifically the technologies and expertise of our collective research and development teams will enable us to provide novel high throughput oral fluid drug testing solutions." The Companies anticipate the first four assays to be available for sale later this year. Several additional assays are also in development and are currently in varying stages of submission with the FDA.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV