Meridian Bioscience Receives FDA CLIA Waiver Status for Stomach Ulcer Test

Meridian Bioscience, Inc. (NASDAQ:VIVO) today announcedthat it has received CLIA waiver status from the U.S. Food and DrugAdministration (FDA) for its ImmunoCard STAT!(R) HpSA test, a rapidsingle-use test for the diagnosis of Helicobacter pylori (H. pylori)infection. The vast majority of peptic ulcer disease is caused byinfection with H. pylori bacteria and, in recent years, effectivetherapies have become available for eradicating this disease. Pepticulcer disease impacts millions of Americans resulting in more than $6billion in healthcare costs each year. ImmunoCard STAT! HpSA is simpleto use and provides accurate results in just minutes from anon-invasive patient sample. This test uses patented technologysimilar to that used in Meridian's Premier Platinum HpSA(R) test andits use is indicated in the diagnosis of H. pylori infection as wellas for monitoring patient response to therapy.

CLIA waiver status means that now doctors' offices can employ"test and treat" medicine designed to eradicate infection whilereducing future risk significantly and reducing healthcare costs.

"ImmunoCard STAT! HpSA offers superior accuracy in a simple formatthat makes the test ideally suited for smaller volume labs thatperform one or two tests at one time," stated John Kraeutler,President and Chief Operating Officer. "Recently, the AmericanGastroenterological Association issued important guidelines thatrecommend against the use of tests that detect H. pylori antibodiesand support the use of direct H. pylori tests (e.g., ImmunoCard STAT!HpSA and Premier Platinum HpSA Plus) prior to prescribingsymptom-relieving drugs. Having received this important CLIA waiverstatus, Meridian will immediately expand its distribution partnershipsto increase access into the physicians' office and clinic markets."

FORWARD LOOKING STATEMENTS

The Private Securities Litigation Reform Act of 1995 provides asafe harbor from civil litigation for forward-looking statementsaccompanied by meaningful cautionary statements. Except for historicalinformation, this report contains forward-looking statements which maybe identified by words such as "estimates", "anticipates", "projects","plans", "seeks", "may", "will", "expects", "intends", "believes","should" and similar expressions or the negative versions thereof andwhich also may be identified by their context. Such statements arebased upon current expectations of the Company and speak only as ofthe date made. The Company assumes no obligation to publicly updateany forward-looking statements. These statements are subject tovarious risks, uncertainties and other factors that could cause actualresults to differ, including, without limitation, the following:Meridian's continued growth depends, in part, on its ability tointroduce into the marketplace enhancements of existing products ornew products that incorporate technological advances, meet customerrequirements and respond to products developed by Meridian'scompetition. While Meridian has introduced a number of internallydeveloped products, there can be no assurance that it will besuccessful in the future in introducing such products on a timelybasis. Ongoing consolidations of reference laboratories and formationof multi-hospital alliances may cause adverse changes to pricing anddistribution. Costs and difficulties in complying with laws andregulations administered by the United States Food and DrugAdministration can result in unanticipated expenses and delays andinterruptions to the sale of new and existing products. Changes in therelative strength or weakness of the U.S. Dollar can change expectedresults. One of Meridian's main growth strategies is the acquisitionof companies and product lines. There can be no assurance thatadditional acquisitions will be consummated or that, if consummated,will be successful and the acquired businesses successfully integratedinto Meridian's operations.

Meridian is a fully integrated life science company thatmanufactures, markets and distributes a broad range of innovativediagnostic test kits, purified reagents and related products andoffers biopharmaceutical enabling technologies. Utilizing a variety ofmethods, these diagnostic products and tests provide accuracy,simplicity and speed in the early diagnosis and treatment of commonmedical conditions, such as gastrointestinal, viral, urinary andrespiratory infections. Meridian diagnostic products are used outsideof the human body and require little or no special equipment. TheCompany's products are designed to enhance patient well-being whilereducing the total outcome costs of healthcare. Meridian has strongmarket positions in the areas of gastrointestinal and upperrespiratory infections, serology, parasitology and fungal diseasediagnosis. In addition, Meridian is a supplier of rare reagents,specialty biologicals and related technologies used bybiopharmaceutical companies engaged in research for new drugs andvaccines. The Company markets its products and technologies tohospitals, reference laboratories, research centers, veterinarytesting centers, physician offices, diagnostics manufacturers andbiotech companies in more than 60 countries around the world. TheCompany's shares are traded through Nasdaq's National Market, symbolVIVO. Meridian's website address is www.meridianbioscience.com.