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TMCNet:  Meridian Bioscience Granted Special 510(k) Clearance for TRU FLU® to Add Avian H7N9 Influenza A Virus Analytical Sensitivity Claim

[January 10, 2014]

Meridian Bioscience Granted Special 510(k) Clearance for TRU FLU® to Add Avian H7N9 Influenza A Virus Analytical Sensitivity Claim

CINCINNATI --(Business Wire)--

Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced that the company's TRU FLU® assay received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU® is a rapid immunoassay that detects influenza A and influenza B viruses in 15 minutes in human respiratory specimens.

New strains of Influenza viruses are continuously emerging to replace the more contemporary or common strains. The novel avian Influenza A strain H7N9 was first reported in China in March 2013. Since then, there have been 147 confirmed human cases of avian influenza A H7N9, with 47 deaths reported in China. It is important that rapid assays are able to detect novel strains as they emerge to enable physicians to deliver prophylaxis to and manage infected patients in a timely manner.

Meridian's TRU FLU and TRU RSV® products provide closed systems that limit the exposure of laboratory personnel to infectious agents in test samples during incubation and disposal.

John A. Kraeutler Chief Executive Officer, stated, "Meridian is committed to providing accurate and rapid diagnostic solutions as novel flu strains emerge globally. During the 2009 H1N1 pandemic, Meridian received special 510(k) FDA clearance to add H1N1 analytical sensitivity claim for TRU FLU. Once again, Meridian knew that it was critically important to be prepared for a potential pandemic with the novel avian H7N9 strain to provide the best patient care."

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 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, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company's shares are traded on NASDAQ's Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.


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