Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene® Pertussis
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
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.
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. The Company’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700