Meridian Bioscience Receives FDA CLIA Waiver Status for Stomach Ulcer Test
CINCINNATI--(BUSINESS WIRE)--June 12, 2006--Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that it has received CLIA waiver status from the U.S. Food and Drug Administration (FDA) for its ImmunoCard STAT!(R) HpSA test, a rapid single-use 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 disease. Peptic ulcer disease impacts millions of Americans resulting in more than $6 billion in healthcare costs each year. ImmunoCard STAT! HpSA is simple to use and provides accurate results in just minutes from a non-invasive patient sample. This test uses patented technology similar to that used in Meridian's Premier Platinum HpSA(R) test and its use is indicated in the diagnosis of H. pylori infection as well as for monitoring patient response to therapy.
CLIA waiver status means that now doctors' offices can employ "test and treat" medicine designed to eradicate infection while reducing future risk significantly and reducing healthcare costs.
"ImmunoCard STAT! HpSA offers superior accuracy in a simple format that makes the test ideally suited for smaller volume labs that perform one or two tests at one time," stated John Kraeutler, President and Chief Operating Officer. "Recently, the American Gastroenterological Association issued important guidelines that recommend against the use of tests that detect H. pylori antibodies and support the use of direct H. pylori tests (e.g., ImmunoCard STAT! HpSA and Premier Platinum HpSA Plus) prior to prescribing symptom-relieving drugs. Having received this important CLIA waiver status, Meridian will immediately expand its distribution partnerships to increase access into the physicians' office and clinic markets."
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", "seeks", "may", "will", "expects", "intends", "believes", "should" and similar expressions or the negative versions thereof 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. The Company assumes no obligation to publicly update any forward-looking statements. 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 diagnostic products and tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral, urinary and respiratory infections. 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, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers and biotech companies 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.