Meridian Bioscience Announces FDA Clearance of New Rapid Test for Severe Colitis
CINCINNATI--(BUSINESS WIRE)--Aug. 26, 2004--Meridian Bioscience, Inc., Cincinnati, Ohio (Nasdaq:VIVO) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market ImmunoCard Toxins A&B, a rapid new test for the diagnosis of a major cause of antibiotic-associated colitis. This test detects the most important toxins produced by strains of the Clostridium difficile bacterium (C. difficile). C. difficile is recognized as the major cause of colitis and diarrhea that may occur following antibiotic therapy. In hospitals or nursing home facilities where C. difficile is prevalent and patients frequently receive antibiotics, the disease affects as many as 38% of those receiving antibiotics. ImmunoCard Toxins A&B is a simple, rapid test that provides clear-cut, color-change results in minutes.
John A. Kraeutler, President and Chief Operating Officer, said, "Our ImmunoCard Toxins A&B test is an ideal diagnostic tool that allows for a rapid `test and treat' response following symptoms. In just minutes, ImmunoCard Toxins A&B can detect both of the clinically significant toxins that often lead to severe colitis. Treatment decisions can be made quickly leading to faster patient recovery. We expect to begin shipping ImmunoCard Toxins A&B to our lab customers within 60 days."
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, urinary and respiratory infections. All Meridian diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents and specialty biologicals along with proteins and other biologicals used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices and diagnostics manufacturers in more than 60 countries around the world. The Company's shares are traded through Nasdaq's National Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, 513-271-3700
SOURCE: Meridian Bioscience, Inc.