Meridian Bioscience Inc. (NASDAQ: VIVO), the Cincinnati, Ohio diagnostic test maker, has received FDA clearance for its new Clostridium difficile test.
The ImmunoCard C. difficile GDH test has already been launched in global markets for screening of the bacteria, a common hospital-acquired infection. Toxigenic strains of C. difficile cause diarrhea and can lead to life-threatening complications or death.
In 2010, researchers reported that the C. difficile superbug surpassed Staphylococcus aureus as the most common hospital-acquired infection in the U.S., infecting about half a million people each year.
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This approval makes Meridian the only manufacturer that can provide a complete portfolio of C. difficile testing solutions, the company said in a press release. Meridian already has a few tests for C. difficile on the market, but sales stagnated last year because of increasing competition. In March, the company received FDA clearance on what it called the only C. difficile test on the market aimed at patients younger than 2 years old.
Just two weeks ago Meridian received FDA approval for a molecular diagnostics test for group B streptococcus, part of its illumigene line of molecular diagnostics.
The company generated net earnings of $26.8 million in fiscal year 2011, flat from 2010. Shares were trading up half a percent at close on Tuesday.
