Meridian Receives FDA 510(k) Clearance for New Molecular Whooping Cough Test Claims

by BusinessWire

CINCINNATI--()--Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new claims for its illumigene® Pertussis molecular amplification test. The upgraded test reduces the effect of inhibitors in biologic samples and significantly expands Meridian’s customer base by including specimens collected by ESwab™ (Copan Diagnostics, Inc.).

ESwab is a multipurpose universal transport system that a significant portion of laboratories in the United States currently use to streamline workflows and eliminate costs associated with stocking multiple swab types.

Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics stated, “We are pleased to be able to offer an upgraded pertussis test that was developed with customer feedback in mind. Continuous product improvement and development successes like this illustrate Meridian’s commitment to our customers, and the patients that they serve. Through efforts like these we believe we will continue to grow our customer base and maintain our market leading position in molecular pertussis testing.”

Often referred to as “whooping cough”, Bordetella pertussis can cause serious illness in infants, children and adults. Each year, there are approximately 16 million reported cases of pertussis worldwide and nearly 200,000 deaths. In the United States alone, almost 33,000 pertussis infections were reported in 2014, which represents a 15% increase compared to 2013.

illumigene Pertussis, by amplifying the specific DNA target for the detection of Bordetella pertussis, provides a definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. By comparison, B. pertussisbacterial 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 procedure is remarkably simple, taking less than sixty minutes to report up to 10 results. 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.

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