FDA categorizes Meridian Bioscience Group A and B strep tests “moderate complexity”

March 21, 2013

Meridian Bioscience has announced that the FDA has re-categorized the company’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 illumigene platform to be available to all Moderate Complexity laboratories in U.S. hospitals and clinics, enabling them to offer a rapid and simple molecular test for either 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 primary care physicians are consulted, with some 15 million visits annually in the United States. According to Meridian representatives, clinical studies have shown 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 infants, associated with significant morbidity and mortality. illumigene Group B Streptococcus fully complies with the Centers for Disease Control and Prevention (CDC) guidelines for the detection of GBS. Meridian reports that studies have shown that broth enrichment, followed by testing with illumigene Group B Streptococcus, increased detection of true positives by 29% over traditional culture, allowing for appropriate treatment at the time of delivery. Read about the company’s Group A and Group B molecular diagnostic systems.