Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene® HSV 1&2
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.
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
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.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700