Diagnostic test kit maker Meridian Bioscience (VIVO) has won the approval of the U.S. Food and Drug Administration (FDA) for its new test for detection of Legionnaire’s disease (legionellosis), a potentially fatal form of pneumonia.
The test, dubbed TRU Legionella, is a rapid lateral flow device which offers optimized detection of Legionella pneumophila serogroup that is most commonly associated with Legionnaire’s disease, which is caused by a type of bacteria called Legionella.
The infection is characterized by symptoms which are typically similar to a severe flu including fever, headache, breathing problems, muscle aches/pains and occasionally a dry cough. Legionnaire’s disease affects around 100,000 Americans annually with roughly 10,000 to 20,000 hospitalizations.
According to Meridian, Legionella is implicated in 5%-8% of the roughly 4 million to 5 million cases of community acquired pneumonia that occur annually in the U.S. However, many infections are left undiagnosed given the poor diagnostic options.
Meridian believes that the TRU Legionella test will provide a much needed solution for the often under-diagnosed Legionnaire’s disease. The test is expected to offer laboratories with a powerful tool for accurate, cost-effective and fast detection of this disease condition, thereby expediting treatment for the affected patients.
Meridian specializes in developing diagnostic test kits for multiple serious and infectious diseases. The company’s diagnostics business faces strong competition from Abbott Laboratories (ABT), Becton, Dickinson and Company (BDX), Thermo Fisher (TMO) and Siemens (SI).
Meridian, in December 2011, received the FDA approval for the illumigene GBS (Group B streptococcus) test, its second in the illumigene molecular test platform. Successively, the company received the U.S. approval for its new C. difficile (Clostridium difficile) test called ImmunoCard C. difficile GDH.
The TRU Legionella test represents a key addition to the company’s respiratory product range. The test reinforces its leadership position in rapid and accurate testing methods for infectious diseases.
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