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

Meridian Bioscience Receives FDA Clearance For New Premier ™ C. Difficile GDH Assay

Stock quotes in this article: VIVO

Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for a new Clostridium difficile immunoassay named Premier™ C. difficile GDH. This product expands the Company’s existing portfolio of C. difficile tests and has been available in Europe and the rest of world since October of 2010. The assay detects a common antigen produced by toxigenic and non-toxigenic forms of C. difficile bacteria. Toxigenic forms of C. difficile are frequently associated with hospital and community acquired diarrhea resulting from antibiotic therapy and, in severe cases, can cause a life-threatening inflammation of the colon. Premier™ GDH is used by laboratories that want to screen patients with diarrhea for both forms of C. difficile. To differentiate those patients at risk of disease with toxin-producing forms of C. difficile, GDH-positive samples should be re-tested with toxin-detecting tests such as Meridian’s Premier™ Toxins A&B or Immuno Card ® Toxins A&B, or with a molecular amplification assay, such as Meridian’s illumigene ® C. difficile test.

Jack Kraeutler, Chief Executive Officer, commented, “ C. difficile can be a very dangerous infection that may lead to severe consequences for both patients and the healthcare institutions that care for them. Clearance of our new Premier™ C. difficile GDH test continues the Company’s long history of breakthrough products for the detection and identification of C. difficile. Meridian introduced its first latex based assay in March, 1990. Shortly thereafter, Meridian scientists confirmed that the “latex-reactive protein” of C. difficile was in fact a glutamate dehydrogenase and not a toxin, as previously thought. Continuing innovation allowed Meridian to launch the first commercially available GDH enzyme immunoassay (Immuno Card ® C. difficile GDH) in January 1993 that was significantly more sensitive than the previous latex based tests. This third generation GDH assay, built on 20 years of C. difficile expertise, should set a new standard for GDH identification and, along with our toxin detection assays and our new illumigene ® molecular platform, affirms our unique position as the one IVD Company that offers complete solutions for C. difficile detection.”

FORWARD LOOKING STATEMENTS

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 16,854.35 -188.55 -1.11%
S&P 500 1,958.47 -13.82 -0.70%
NASDAQ 4,450.1180 -43.2720 -0.96%

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