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FDA Recategorizes Meridian's Molecular Strep A and B Assays as 'Moderate Complexity' Tests

NEW YORK (GenomeWeb News) – Meridian Bioscience said on Monday that its illumigene Group A Streptococcus and illumigene Group B Streptococcus assays have been recategorized by the US Food and Drug Administration as "moderate complexity" tests under the Clinical Laboratory Improvement Amendments.

Tests designated as such are considered to be simple and easy to use. As a result of the recategorization, the benefits of Meridian's illumigene platform will be available to moderate complexity labs in US hospitals and clinics, "empowering them to offer an accurate, rapid, simple molecular test for each of these pathogens," the Cincinnati-based company said.

"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," Meridian CEO Jack Kraeutler said in a statement. "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."

The FDA cleared the Group A Streptococcus test in September 2012 and the Group B Streptococcus test in December 2011.

The Group A and Group B Streptococcus tests were originally categorized as High Complexity by FDA, but were recategorized as Moderate Complexity after Meridian questioned the agency, Kraeutler told GenomeWeb Daily News.