Meridian Bioscience Snags FDA OK for New Molecular Amplification Test: illumigene HSV 1&2
CINCINNATI--(BUSINESS WIRE)--
Meridian Bioscience, Inc. (VIVO) today announced that it has received FDA clearance for two new molecular assays for the detection of Herpes Simplex Virus Type 1 (HSV-1) and Type 2 (HSV-2), to be run on its illumigene® molecular platform. The illumigene® HSV 1&2 assays, launched earlier this year in Europe, are now available immediately in the US – they are the eighth and ninth assays added to the illumigene® molecular menu now that includes; C. difficile, Group A Streptococcus, Group B Streptococcus, Mycoplasma, Pertussis, Chlamydia and Gonorrhea.
The CDC estimates that more than 50 million people in the US are living with HSV-2 and roughly one out of every six people aged 14-49 have genital herpes, making it the second most prevalent sexually transmitted infection in the country. In addition, it is estimated that roughly 54% of Americans now have HSV-1. HSV is a major health concern because both HSV-1 and HSV-2 can be transmitted perinatally from mother to child, and in some cases, cause fatal infection in infants. Other serious complications from HSV-1 and HSV-2 include blindness, encephalitis, aseptic meningitis and an increased risk of acquiring and transmitting HIV infection.
Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics stated, “With more than 775,000 new cases of HSV-2 annually, and the majority of infections transmitted by people unaware of their infection,offering a test solution that allows providers to collect, test and treat same in the day is paramount.Currently, approximately 60% of hospital laboratories are sending out their HSV-1 and HSV-2 test requests to an offsite testing facility, and a smaller percentage are performing viral culture in-house; both scenarios can take up to 1 week to report final results, creating an unnecessary delay in the delivery of patient care and the potential for transmission of the virus to new contacts.”
illumigene® HSV 1&2 assays utilize loop-mediated isothermal DNA amplification (LAMP) technology for the qualitative detection and differentiation of HSV-1 and HSV-2 in cutaneous and mucocutaneous specimens. The test procedure is remarkably simple, highly sensitive and provides results in less than one hour. The illumigene platform does not require expensive capital equipment or costly annual service contracts. The performance and simplicity of this technology, along with its cost efficiency and small footprint, make these new assays ideal for enabling a more rapid diagnosis in a moderately complex laboratory setting.
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, and its ability to effectively sell such products. 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 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 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, 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 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 develops, 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 health care. 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, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
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- Health Care Industry
John A. Kraeutler, Chief Executive Officer, 513-271-3700