New Malaria Test, illumigene® Malaria, Sets a New Gold Standard for Diagnosis

CINCINNATI, 2016-01-26 13:30 CET (GLOBE NEWSWIRE) --

Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that it has received the CE Mark for illumigene^® Malaria, a novel, highly accurate  test developed by Meridian with the technical assistance of the Centers for Disease Control and Prevention (CDC) and Cheikh Anta Diop University of Dakar, Senegal. The test is up to 80,000 times more sensitive at detecting the malaria parasite than conventional tests, potentially revolutionizing malaria diagnosis and establishing a new gold standard. Using innovative molecular LAMP technology, illumigene results are available in under one hour, and the test is easy to use as it does not rely on high level technical expertise. This is a major step forward for people with malaria as faster, more accurate diagnoses should lead to prompt treatment and better outcomes.  illumigene Malaria will be distributed in the European, Middle Eastern and African regions by Meridian Bioscience Europe and in additional international markets by the Company’s global distribution network.

Despite a 60% decline in malaria deaths since 2000, because of better prevention and increased control measures, malaria is still one of the top three killers of children worldwide claiming one life every minute of every day.  Malaria is no longer only a disease of sub-Saharan Africa and southern Asia. Increasing numbers of people emigrating from countries where malaria is endemic have resulted in a higher incidence in Europe and the Middle East.  The proportion of imported malaria cases has increased during the last few years from 14% to 86% in more recent studies. On pooling the reports, nearly 43% of malaria cases registered in key European centers occurred in non-nationals. The rates of malaria are much higher in settled immigrants who travel to visit friends and relatives (VFRs) in their country of origin. They can account for up to 70% of the cases in several reports and this increase highlights the need for better diagnostic tools in both non-endemic and endemic countries.

“illumigene Malaria has the potential to change current practices. Faster and more accurate diagnosis is vital in the fight against malaria. Earlier diagnosis enables the correct treatment to be prescribed which leads to better clinical outcomes for the person with malaria and keeps malaria treatments for the right people.  Because of submicroscopic parasitemia carriage among the populations, a robust, sensitive and field community-deployable screening tool is needed to track the malaria reservoir in pre-elimination regions. illumigene Malaria shows this capacity,” said Professor Daouda NDIAYE, Department of Parasitology-Mycology, Cheikh Anta Diop University of Dakar, Senegal.

Meridian Bioscience has worked actively with leading experts at the CDC and the Cheikh Anta Diop University of Dakar during the development of illumigene Malaria and collaborated with these organizations to design clinical trials. Data from over 200 patients from Senegal validated the performance of illumigene Malaria. The test demonstrated 100% sensitivity, but more importantly, it also detected infected patients that were missed by conventional methods for the identification of Malaria.

“Patient care is central to Meridian’s work and we consider the needs of all those involved in diagnosis when developing our products. Malaria remains one of the most dangerous diseases in the world both in endemic and increasingly non-endemic countries. illumigene Malaria delivers a high level of sensitivity combined with a quick turnaround time and simple procedure, a combination of attributes that have been lacking in this disease area. Malaria is the tenth assay now available on our illumigene platform that is in use in nearly 1,500 institutions around the world.  We are proud to be able to join the fight against Malaria with our flagship illumigene molecular technology.” said Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics.

Notes to Editors:

About Professor Daouda Ndiaye, PharmD, MsC, PhD

• Professor Ndiaye is Professor of Parasitology and Mycology and Director of the Senegal African Centre for Excellence on Genomic and Infectious Diseases, based at the University Cheikh Anta Diop, Senegal
• Professor Ndiaye gained his PhD from Harvard University and is currently a visiting scientist at the Harvard TH Chan School of Public Health, Department of Immunology and Infectious Diseases
• Professor Daouda Ndiaye will be available for interview upon request.
   

About illumigene® Malaria & LAMP Technology

• illumigene Malaria is a diagnostic test for malaria developed by Meridian Bioscience. It is a molecular test that uses Loop-Mediated Isothermal Amplification (LAMP) technology to amplify DNA and detect the presence of the Malaria parasite
• LAMP technology is isothermal and so can be used at room temperature without the need to heat reagents or the material being tested, unlike the rapid diagnostic tests currently used in Malaria which use polymerase chain reaction (PCR) technology. illumigene Malaria does not require refrigeration.
• Illumigene technology is simple, accurate and easy to use which means that no specialist technical expertise is needed to use the test. Results are available in under an hour.
• LAMP based illumigene tests are already used to diagnose infectious diseases including C. difficile, whooping cough and Herpes Simplex Virus, where they have proved highly accurate.
• Illumigene tests have been approved and used in other diseases for over 5 years.
   

About Meridian Bioscience, Inc

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 70 countries around the world. The Company’s shares are traded on NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.

For news coverage on product information regarding illumigene® Malaria including interview requests and images (photography of Professor Ndiaye’s Senegal clinic is available) please contact:

• For UK and pan-European: Sarah Herbert, Sarah.Herbert@mslgroup.com on +44 203 219 8708
• For France: Barbara Joly – Barbara.Joly@mslfrance.com on  +33 6 61 19 97 96
• For Spain: Lucia Sixto - lucia@marcodecomunicacion.com on +34 93 635 05 00  
• For Italy: Antonella Di-Fatta - antonella.di-fatta@publicisconsultants.it on +39 33 47 15 13 18  
• For Saudi Arabia: Nahed Ashour - Nahed.ashour@cnc-communications.com on +971 50 820 8100

 

Contact: 513.271.3700
John A. Kraeutler, Chief Executive Officer