Meridian Bioscience, Inc. (VIVO) Receives FDA Clearance for New Molecular Test: illumigene® Group B Streptococcus
12/12/2011 7:40:58 AM
CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced that it has received FDA clearance for a new molecular diagnostic test for Group B Streptococcus (GBS) on the illumigene® platform. This innovative test is a strong addition to the illumigene platform. Group B Streptococcus, or GBS, continues to be a major perinatal pathogen, for both mothers and their infants, and is associated with significant morbidity and mortality. The CDC recommendations for GBS, published in November of 2010, indicated that a universal culture-based screening method should be performed at 35 to 37 weeks of gestation. (MMWR Vol 59 NoRR-10) The illumigene GBS test allows laboratories to comply with the CDC recommendations while benefitting from a simplified workflow and greater sensitivity for early diagnosis and proper management. Donna Mayne, Supervisor of the Microbiology, Serology and Molecular Laboratories at Sacred Heart Hospital in Pensacola, Florida states, “illumigene GBS fully complies with the CDC guidelines for the detection of Group B Streptococcus (GBS) and is the most sensitive test on the market. Broth enrichment plus illumigene GBS empowers my laboratory to provide the highest standard of care for my patients. The simplified procedure will allow my laboratory to report accurate, definitive results in less time than culture.”
The illumigene GBS test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae in enriched cultures of samples from women. The test procedure is remarkably simple, highly sensitive, and yields results in less than one hour. It requires no expensive capital equipment. The test relies upon a simple procedure that includes heat treatment, amplification and detection. The entire amplification is isothermal and results are read on the illumipro-10™ instrument. All reagents and disposables are contained in the test kit and can be stored at room temperature. Meridian believes that the “point-of-care” simplicity of this technology, along with its cost efficiency, make this innovative test ideal for helping in early diagnosis and proper management of this preventable disease, especially in those instances where there is a low level of the biological target.
Richard Eberly, Chief Commercial Officer stated, “illumigene GBS is a key addition to the illumigene platform given the importance of early detection of GBS to prevent serious disease in infants. This new test begins the expansion of the illumigene platform and provides a molecular technology that is affordable, simple, and quick. Our technology continues to appeal to any size acute care laboratory that is seeking molecular amplification capability with no capital investment and the ultimate in simplicity and accuracy.”
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. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The Company 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 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. Meridian relies on proprietary, patented and licensed technologies and 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. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar, can make results difficult to predict. 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 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. The Company cannot predict the possible effects of recently-enacted United States healthcare legislation and any similar initiatives in other countries on its results of operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.
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 and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s 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, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700
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