Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene® Pertussis

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Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it 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.

March 27, 2014

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it 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.

Often referred to as “whooping cough”, Bordetella pertussis can cause serious illness in infants, children and adults. The worldwide incidence of pertussis has been on the increase over the past 30 years. Each year, there are approximately 16 million reported cases of pertussis and nearly 200,000 deaths. In the United States alone, more than 48,000 pertussis infections were reported in 2012; the highest number of cases reported in the country since 1955.

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.

John A. Kraeutler, Chief Executive Officer, stated, “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 Pertussisdiagnosis; both scenarios can take over a week to report a final result, increasing the time to manage the patient appropriately. With illumigenePertussis, healthcare providers can collect, test and treat same day for optimal patient management. Meridian is dedicated to the development of rapid, simple, cost effective diagnostic tests and technologies that aid in the reduction of overall healthcare costs. illumigene Pertussis will be available for market within 30 days.”

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company’s products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world.

See the press release here.

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