Meridian Bioscience Announces New Rapid Test for Stomach Ulcers
CINCINNATI--(BUSINESS WIRE)--Dec. 9, 2003--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 STAT!(R) HpSA, a rapid new test for the diagnosis of Helicobacter pylori (H. pylori) infection. The vast majority of peptic ulcer disease is caused by infection with H. pylori bacteria and, in recent years, effective therapies have become available for eradicating this pathogen. ImmunoCard STAT! HpSA is simple and provides accurate, easy-to-read results in just minutes from a non-invasive patient sample. Meridian has been an innovator and a leader in H. pylori diagnostics since 1991. This test utilizes patented technology similar to that used in Meridian's Premier Platinum HpSA test and its use is indicated to aid in the diagnosis of H. pylori infection as well as for monitoring patient response to therapy. In addition, ImmunoCard STAT! HpSA has been cleared for use on both children and adults.
Peptic ulcer disease impacts millions of Americans resulting in more than $6 billion in healthcare costs each year. While the incidence of infections in the U.S. is approximately 30% of the population, on a worldwide basis, incidence of infection can reach 80%. Studies have linked H. pylori infection with certain late-onset stomach cancers in addition to its role as a primary cause of stomach ulcers. With the availability of this test, clinicians are now better prepared to employ "test and treat" medicine which is designed to eradicate infection while reducing future risk and helping to significantly reduce healthcare costs.
"This new rapid test for the bacteria that causes most stomach ulcers and, potentially, other serious conditions, will be an important tool in the diagnosis and treatment of persons at risk," stated John Kraeutler, President and Chief Operating Officer. "The suffering related to gastric problems associated with H. pylori infections is widespread and symptom relieving treatment is expensive. ImmunoCard STAT! HpSA represents a milestone in diagnostic testing that can improve patient well-being significantly while removing meaningful costs from our overburdened healthcare system."
Forward Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements which may be identified by words such as "estimates", "anticipates", "projects", "plans", "expects", "intends", "believes", "should", and similar expressions and which also may be identified by their context. Such statements are based upon current expectations of the Company and speak only as of the date made. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ, including, without limitation, the following.
Meridian's continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian's competition. While Meridian has introduced a number of internally-developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Costs and difficulties in complying with laws and regulations administered by the United States Food and Drug Administration can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. Changes in the relative strength or weakness of the U.S. dollar can change expected results. One of Meridian's main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses successfully integrated into Meridian's operations.
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.