Meridian Bioscience, Inc., Cincinnati, Ohio 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 revolutionising 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 centres 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 parasitaemia 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 1500 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.