Meridian Bioscience Inc. (VIVO) Monday said that US Food & Drug Administration has re-categorized its illumigeneGroup A Streptococcus and illumigene Group B Streptococcus tests as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments.
Moderately complex tests are assays that are considered to be simple and easy to use. The categorization allows the benefits of the illumigene platform to be available to all Moderate Complexity laboratories that are in US hospitals and clinics, empowering them to offer an accurate, rapid, simple molecular test for each of these pathogens.
illumigene Group A Streptococcus is a qualitative molecular test 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.
Group B Streptococcus continues to be a major perinatal pathogen, for both mothers and their infants, and is associated with significant morbidity and mortality.
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