Meridian Bioscience secures CE mark for new molecular diagnostic test

27 April 2016 (Last Updated April 27th, 2016 18:30)

US-based life science company Meridian Bioscience has secured the CE mark for its new molecular diagnostic test 'illumigene Mycoplasma Direct' to detect Mycoplasma pneumonia (M. pneumonia).

pneumonia

US-based life science company Meridian Bioscience has secured the CE mark for its new molecular diagnostic test illumigene Mycoplasma Direct to detect Mycoplasma pneumonia (M. pneumonia).

The new illumigene Mycoplasma Direct assay is said to be a simple process which eliminates the requirement of special techniques and training and generates fast results.

Meridian Global Diagnostics executive vice-president and president Mike Shaughnessy said: "By simplifying the procedure we are able to provide more customers with a superior diagnostic tool that will improve patient care.

"Due to the lack of cell wall in Mycoplasma, typical antibiotics like penicillin and cephalosporin are not effective, making rapid, targeted detection for appropriate treatment of the utmost importance."

The diagnostic test is categorised under the illumigene group which includes molecular tests for Group A Streptococcus, Pertussis, C difficile, Chlamydia, Gonorrhea, HSV 1&2, Group B Streptococcus, and Malaria.

"Due to the lack of cell wall in Mycoplasma, typical antibiotics like penicillin and cephalosporin are not effective, making rapid, targeted detection for appropriate treatment of the utmost importance."

M. pneumoniae, often called walking pneumonia has become increasingly widespread across European countries, symptoms of which include headaches, malaise, fever and sore throat accompanied by dry, paroxysmal cough.

illumigene Mycoplasma Direct gives an immediate result once administered to the patient, by amplifying the specific DNA for the detection of an active mycoplasma pneumoniae infection.

It uses throat swabs and is said to provide sensitive and specific results without requiring expensive capital equipment or service contract.

The test involves a simple procedure that takes less than two minutes. The technology facilitates a rapid diagnosis; providing earlier identification of outbreaks and prevention of secondary cases through implementation of control measures.


Image: Mycoplasma pneumoniae cells attached to ciliated mucosal cells. Photo: courtesy of Rottem et al.