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FDA Clearance for Meridian illumigene Pertussis

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. This innovative test is the first FDA-cleared molecular stand-alone assay for B. pertussis providing a solution to the unmet need of today’s healthcare market.

illumigene Pertussis, by amplifying the specific DNA target for the detection of Bordetella pertussis, represents a significant advancement in improving healthcare diagnoses and outcomes by providing a definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. By comparison, B. pertussis bacterial culture lacks sensitivity and is often impractical for patient management; also healthcare providers that send out to reference laboratories may have to wait more than a week for a test result delaying the necessary treatment for the patient.

The illumigene Pertussis test is the fifth assay on the illumigene platform and utilizes nasopharyngeal swab samples. The test procedure is remarkably simple, taking less than sixty minutes to report a result. It requires no expensive capital equipment, and no costly annual service contracts. The simplicity of this technology, along with its cost efficiency and small footprint, makes this innovative test ideal for enabling a more rapid diagnosis; providing earlier identification of outbreaks and prevention of secondary cases through implementation of control measures.


     
Tags: Bordetella, Bordetella pertussis

Date Published: April 1, 2014

Source article link: Meridian Bioscience, Inc. » company contact details
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