Meridian Bioscience receives FDA clearance for B. pertussis molecular amplification test

April 2, 2014

Meridian Bioscience, Inc., has received FDA clearance for a new molecular diagnostic test for Bordetella pertussis (B. pertussis), its fifth assay on the illumigene platform. illumigene pertussis is a molecular stand-alone assay that amplifies the specific DNA target for the detection of the causative agent of “whooping cough.” According to company representatives, the test represents a significant advancement in improving diagnoses and outcomes by providing a definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. They compare it favorably to B. pertussis bacterial culture, asserting that the latter lacks sensitivity and is often impractical for patient management.

The illumigene Pertussis test, the fifth assay on the illumigene platform, utilizes nasopharyngeal swab samples. The test procedure is straightforward, taking less than sixty minutes to report a result. It requires no expensive capital equipment and no costly annual service contracts. Meridian is stressing its simplicity, cost efficiency, and small footprint, and its utility for rapid diagnosis.

John A. Kraeutler, Chief Executive Officer, states, “Although whooping cough is said to be on the rise, Bordetella pertussis is under-diagnosed and under-reported. Currently hospital laboratories are performing bacterial culture; however, most labs are sending out for a pertussis diagnosis. Both scenarios can take more than 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.” illumigene Pertussis will be available for market within 30 days.

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