FDA Clearance for Whooping Cough Molecular Amplification Test: illumigene® Pertussis

FDA clearance for Bordetella pertussis genetic assay represents significant advancement in improving healthcare diagnostics

Meridian Bioscience, Inc., Cincinnati, Ohio has 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.”

To watch a video on illumigene LAMP technology, please click here.

Image caption: The illumigene Pertussis test is performed on the illumigene platform