Shares of Meridian Bioscience, Inc. (NASD:VIVO) gained as much as 2.4% following the announcement of the company’s receipt of the U.S. Food and Drug Administration’s (:FDA) clearance for its TRU FLU assay for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. The stock ended the trading session at $27.24 on Jan 10, gaining 0.6%.

This regulatory nod follows the special 510(k) FDA clearance received by the company to add H1N1 analytical sensitivity claim for TRU FLU, during the 2009 H1N1 pandemic.

TRU FLU is a rapid, qualitative, lateral-flow immunoassay that is used to detect both influenza A and influenza B viruses. However, the test does not detect influenza C viruses. It can detect the presence of the virus in no more than 15 minutes in human respiratory specimens.

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

The FDA approval will help Meridian to commercialize the product and boost its revenues. The commercial availability of TRU FLU with H1N1 analytical sensitivity claim will allow medical professionals to timely detect the presence of these viruses in patients.

Timely and accurate detection, in turn, will help save lives as new strains of influenza viruses are continuously being discovered, challenging healthcare experts. It has been observed that even common strains are becoming increasingly complex to treat.

The recent breakout of the avian Influenza A strain H7N9 in March 2013 in China saw 47 people killed on account of the infection.

Meridian works toward equipping physicians such that they are able to tackle the occurrence of such pandemics. Developments such as the FDA nod for its TRU FLU assay can be considered milestones for the company that increases its scope to occupy a competitive position in the healthcare industry.

Currently, VIVO carries a Zacks Rank # 3 (Hold). Investors interested in the industry can look at better-ranked stocks like Cardiovascular Systems Inc. (:CSII), Mead Johnson Nutrition Co. (NYSE:MJN) and TG Therapeutics, Inc. (NASD:TGTX), each carrying a Zacks Rank #1 (Strong Buy).

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