Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test

Published: Tuesday, June 11, 2013
Last Updated: Tuesday, June 11, 2013
Bookmark and Share
This innovative test that aids in identifying an important respiratory pathogen is a strong addition to the illumigene platform.

Often referred to as “walking pneumonia”, M. pneumoniae has been associated with up to 40% of community-acquired pneumonias. Infection occurs in both children and adults without geographical, gender or climate-related restrictions. M. pneumoniae is most often associated with atypical pneumonia, presenting with symptoms that include headache, malaise, myalgias, fever, and sore throat accompanied by dry, paroxysmal cough. An estimated 2 million cases of M. pneumoniae infection occur annually with approximately 100,000 pneumonia-related hospitalizations in the United States each year. An estimated 18% of M. pneumoniae cases in children require hospitalization.

illumigene Mycoplasma, by amplifying the specific DNA for the detection of Mycoplasma pneumoniae, 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. M. pneumoniae bacterial culture lacks sensitivity and is often impractical for patient management as the organism may take as long as up to six weeks to culture.

The illumigene Mycoplasma test is the fourth assay on the illumigene platform and utilizes both throat and nasopharyngeal swab samples. The test procedure is remarkably simple and highly sensitive, allowing the flexibility of multiple specimen types. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. 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 though implementation of control measures.

“Up to 40% of community-acquired pneumonia is caused by Mycoplasma pneumoniae and due to rising rates of M. pneumoniae resistance to the macrolides commonly prescribed, the more rapid and accurate result that the illumigene Mycoplasma assay provides will allow for better patient care and safety,” stated Dr. Paul Lephart, Associate Technical Director of Microbiology, Detroit Medical Center University Laboratories.

John A. Kraeutler, Chief Executive Officer, stated, “As a significant cause of community-acquired pneumonia, Mycoplasma pneumoniae is under-diagnosed and under-reported. With illumigene Mycoplasma, laboratories can offer healthcare providers fast, accurate information so that patients may receive a definitive diagnosis and rapid, appropriate antibiotic therapy. 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 Mycoplasma will be available for delivery to our customers by month end.”

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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
ReadCoor Launched to Commercialize 3D Sequencing Tech
ReadCoor will leverage the Wyss Institute’s method for simultaneously sequencing and mapping RNAs within cells and tissues to advance development of diagnostics.
Crispr Toolbox Expanded By Protein
Researchers have shown a newly discovered CRISPR protein has two distinct RNA cutting activities.
Heart Arrhythmia Caused by Mosaic of Mutant Cells
Researchers have solved the genetic mystery of an infant suffering from heart arrhythmia.
Over Two-Thirds of Cervical Cancer Deaths Prevented
Cervical screening prevents 70% of cervical cancer deaths and if all eligible women regularly attended screening this would rise to 83%.
Detecting Bacterial Infections in Newborns
Researchers tested an alternative way to diagnose bacterial infections in infants—by analyzing RNA biosignatures from a small blood sample.
Case for Liquid Biopsies Builds in Advanced Lung Cancer
Study addresses unmet need for better, non-invasive tests called out in recent "Moonshot" blue ribbon panel report
Mechanisms of Parkinson’s Pathology
Defects that lead to cells’ failure to decommission faulty mitochondria cause nerve cells to die, triggering the symptoms of Parkinson’s disease.
Genetic Misdiagnoses of Heart Condition
Analysis found several genetic variations previously linked with a heart condition were harmless, leading to condition misdiagnosis.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!