Meridian Bioscience Granted Special 510(k) Clearance for Avian H7N9 Influenza A Virus Sensitivity Claim

Meridian Bioscience, Inc. today announced that the company's TRU FLU(R) assay received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU(R) 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(R) 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."