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Published On: Thu, Sep 20th, 2012

Meridian Bioscience, Inc. announces receiving FDA clearance for new molecular test for Group A Streptococcus

Cincinnati, Ohio company, Meridian Bioscience, Inc announced this week that it received clearance from the Food and Drug Administration (FDA) to market a new molecular diagnostic test for Group A Streptococcus.

Group A streptococcus

Note the inflammation of the oropharynx and petechiae, or small red spots on the soft palate caused by Strep Throat.
Credits: CDC

According to a Meridian Bioscience press release, the illumigene Group A Strep represents a significant new advancement in healthcare by providing a molecular solution for the detection of Group A Strep pharyngitis. Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States. Approximately 20-30% of children seeking physician care are diagnosed with Group A Strep pharyngitis. Traditional laboratory diagnosis is performed by rapid antigen testing or throat swab culture. Studies show that culture may miss up to 10% of true positives.

Accurate diagnosis of streptococcal pharyngitis followed by appropriate antibiotic therapy is important for the prevention and control of Group A Strep infections. The illumigene Group A Strep test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes in throat samples. The test procedure is remarkably simple and highly sensitive. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. All reagents and disposables are contained in the test kit and can be stored at room temperature. The simplicity of this technology, along with its cost efficiency, make this innovative test ideal for helping in early diagnosis and proper patient management of this common and serious disease.

Chief Commercial Officer, Rick Eberly said, “illumigene Group A Strep is a significant addition to Meridian’s illumigene menu, especially as it offers the advantages of both faster and more accurate strep throat diagnostic results. This test continues the expansion of our illumigene technology, which allows healthcare professionals to implement a sophisticated molecular amplification test that is affordable, quick and easily administered in any lab or hospital setting.”

Group A Streptococcus is a bacterium commonly found in the human throat or on skin and causes a wide variety of diseases in humans, the most common being acute pharyngitis or strep throat. Group A Streptococcus infections may result in mild illness (e.g. pharyngitis, impetigo) or may lead to invasive, life-threatening illness such as acute rheumatic fever, cellulitis, bacteremia, necrotizing fasciitis, or Streptococcal toxic shock syndrome.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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