DiaSorin and Meridian Enter Into a Strategic Collaboration to Sell Helicobacter Pylori Stool Antigen Test in the United States and in the United Kingdom

SALUGGIA, Italy and CINCINNATI, Oct. 09, 2018 (GLOBE NEWSWIRE) -- DiaSorin S.p.A. (FTSE Italy Mid Cap: DIA) and Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that DiaSorin Inc., a subsidiary of DiaSorin S.p.A. and Meridian Bioscience, Inc. have entered into a strategic collaboration to sell DiaSorin’s FDA-cleared Helicobacter pylori stool antigen test to detect H. pylori for use on its automated LIAISON platform under the Meridian brand name worldwide. 

As part of this agreement, Meridian and DiaSorin will begin collaborating on sales and marketing efforts to hospitals and reference laboratories in the U.S. Moreover, Meridian will receive royalties on sales of the LIAISON H. pylori stool antigen test in the U.S. and now also in the UK, in addition to the royalties received under the previous agreement.

This new collaboration will result in the termination of all pending legal disputes and will expand the scope of the previous agreement between DiaSorin and Meridian, which focused on the sale, by DiaSorin, of co-developed products in major countries in continental Europe. 

Helicobacter pylori is one of the most common bacterial infections in humans, affecting nearly 50% of the world’s population and it has been associated with the development of serious upper gastrointestinal (GI) conditions including chronic gastritis, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT).

Additionally, Meridian and DiaSorin have outlined a framework where they may partner to develop other stool-based tests for use on the LIAISON platform.

Carlo Rosa, Chief Executive Officer at DiaSorin, commented “We are pleased to enter into this collaboration with Meridian Bioscience. Our stool testing products have been very successful and we are confident that, through this alliance with Meridian, we can continue to expand the adoption of our automated LIAISON platform and its large menu of tests in key markets, like the U.S. and UK. This collaboration creates synergies between state-of-the-art products and technology, which will result in expanded access to a fully automated test for the detection of H. pylori antigen in stool. Moreover, I’m confident that DiaSorin and Meridian will be able to develop additional stool-based tests, leveraging a reliable technology, a broad menu offer for the clients and a large chemiluminescent platform installed base worldwide.”

Jack Kenny, Chief Executive Officer at Meridian Bioscience, continued, “We are excited to team up with DiaSorin to facilitate the advancement of automated HpSA testing. Working together with DiaSorin, we believe we can accelerate the growth in testing to detect helicobacter pylori, a cause of stomach ulcers. Importantly, today many patients suffering from stomach ulcers are not tested, or are tested with less effective serology methods. Non-invasive stool testing platforms are highly accurate and cost effective. Furthermore, these tests can be used in the monitoring and testing of eradication of the H. pylori infection. DiaSorin and Meridian have enjoyed a collaborative relationship for almost ten years. I look forward to further strengthening this relationship as we embark upon this new partnership.”

About DiaSorin Group

Headquartered in Italy and listed in the FTSE Mid Cap Index, DiaSorin is a global leader in the In Vitro Diagnostic (IVD) field. For over 50 years the Company has been developing, producing and marketing reagent kits for IVD worldwide. Through constant investments in research and development, and using its own distinctive expertise in the field of immunodiagnostics to deliver a high level of innovation, DiaSorin offers today the broadest range of specialty tests available in the immunodiagnostics market and new tests in the molecular diagnostics markets, which identify DiaSorin Group as the IVD “Diagnostic Specialist.”

More info at www.diasorin.com

About Meridian Bioscience, Inc.

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.

Meridian’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com

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 within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, 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.  All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted earnings and revenue, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made.  Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance.  Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized.  These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:

Meridian’s operating results, financial condition and 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, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations.  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 or in protecting its intellectual property, and unexpected or costly manufacturing costs associated with the ramp up of new products could cause actual results to differ from expectations.  Meridian relies on proprietary, patented and licensed technologies.  As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results.  Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution.  Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers, can change expected results.  Costs and difficulties in complying with laws and regulations, including those 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, as can the uncertainty of regulatory approvals and the regulatory process.  The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict.  One of Meridian’s 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 will be successfully integrated into Meridian’s operations.  There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention, and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives.  Meridian cannot predict the outcome of goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results.  Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof initiated by Congress or the presidential administration, and any similar initiatives in other countries on its results of operations.  Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems, and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and revenues.  In the past, the Company has identified a material weakness in our internal control over financial reporting, which has been remediated, but the Company can make no assurances that a material weakness will not be identified in the future, which if identified and if not properly corrected, could materially adversely affect our operations and result in material misstatements in our financial statements.  In addition to the factors described in this paragraph, as well as those factors identified from time to time in our filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of our most recent Annual Report on Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.  Readers should carefully review these forward-looking statements and risk factors, and not place undue reliance on our forward-looking statements.

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