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FDA Clears Meridian Illumigene Pertussis Test

NEW YORK (GenomeWeb News) — Meridian Bioscience said today that it has received US Food and Drug Administration clearance for its Illumigene Bordetella pertussis molecular diagnostic test.

The Illumigene Pertussis test is the fifth assay on Meridian's Illumigene platform, which is based on loop-mediated isothermal amplification. The test amplifies a specific DNA target to detect B. pertussis, providing a definitive result and helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner, the company said.

The test uses nasopharyngeal swab samples and takes less than sixty minutes to report a result. It requires no expensive capital equipment and no costly annual service contracts, Meridian said.

"Although whooping cough is said to be on the rise, Bordetella pertussis is under-diagnosed and under-reported," Meridian CEO John Kraeutler said in a statement. "Currently, hospital laboratories are performing bacterial culture; however, most labs are sending out for a pertussis diagnosis; both scenarios can take over a week to report a final result, increasing the time to manage the patient appropriately. With Illumigene Pertussis, healthcare providers can collect, test, and treat same day for optimal patient management."

Meridian said that the assay will be available within 30 days.