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Meridian Bioscience Receives FDA CLIA Waiver Status for Stomach Ulcer Test.


CINCINNATI -- Meridian Bioscience, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:VIVO (Video In Video Out) Refers to a display adapter with analog video capture and analog video out (NTSC out) capabilities. See display adapter. ) today announced that it has received CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a  waiver status from the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) for its ImmunoCard STAT!(R) HpSA test, a rapid single-use test for the diagnosis of Helicobacter pylori Helicobacter pylori
A gramnegative rod-shaped bacterium that lives in the tissues of the stomach and causes inflammation of the stomach lining.

Mentioned in: Indigestion, Ulcers

Helicobacter pylori
 (H. pylori) infection. The vast majority of peptic ulcer disease Peptic ulcer disease (PUD)
A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices.

Mentioned in: Indigestion

peptic ulcer disease See Duodenal ulcer, Gastric ulcer, GERD.
 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 Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
. "Recently, the American Gastroenterological Association The American Gastroenterological Association is a medical association of gastroenterologists. About 14,000 scientists and physicians are members of the organization, which was founded in 1897 and is the oldest medical association in the United States.  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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 provides a safe harbor from civil litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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 United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 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 Serology

The division of biological science concerned with antigen-antibody reactions in serum. It properly encompasses any of these reactions, but is often used in a limited sense to denote laboratory diagnostic tests, especially for syphilis.
, parasitology Parasitology

The scientific study of parasites and of parasitism. Parasitism is a subdivision of symbiosis and is defined as an intimate association between an organism (parasite) and another, larger species of organism (host) upon which the parasite is
 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.
COPYRIGHT 2006 Business Wire
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Publication:Business Wire
Geographic Code:1USA
Date:Jun 12, 2006
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