Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced the U.S. Food & Drug Administration (FDA) has re-categorized Meridian’s illumigene ® Group A Streptococcus and illumigene ® Group B Streptococcus tests as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). Moderately complex tests are assays that are considered to be simple and easy to use.
The Moderate Complexity categorization of both of these tests allows the benefits of the illumigene platform to be available to all Moderate Complexity laboratories that are in U.S. 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, with an estimated 15 million visits per year in the United States. Clinical studies show that illumigene Group A Streptococcus increased detection of positives by 53% over traditional culture in symptomatic patients.
Group B Streptococcus (GBS) continues to be a major perinatal pathogen, for both mothers and their infants, and is associated with significant morbidity and mortality. illumigene Group B Streptococcus fully complies with the CDC guidelines for the detection of GBS and clinical studies have shown that broth enrichment, followed by testing with illumigene Group B Streptococcus, increased detection of true positives by 29% over traditional culture, thus allowing for appropriate treatment of mother at time of delivery, ensuring the best outcome for baby.Jack Kraeutler, Chief Executive Officer, stated, “Due to its simplicity and superior accuracy, our illumigene technology platform enables most clinical labs to perform sophisticated molecular diagnostics without the high costs of capital equipment and ongoing service charges. The Moderate Complexity classification of the illumigene Group A Streptococcus test and the illumigene Group B Streptococcus test, along with illumigene C. difficile, enables more labs to adopt molecular testing thereby helping to provide better patient outcomes.” Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded on NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.