illumigene® Malaria, a novel, highly accurate test developed by Meridian Bioscience, has been awarded the coveted Journées Internationales de Biologie prize for Innovation in emergency treatment and point of care testing.
The innovative new molecular test, which uses Loop-Mediated Isothermal Amplification (LAMP) technology to amplify DNA, is up to 80,000 times more sensitive at detecting the malaria parasite than conventional diagnostic tests. The award recognizes the potential of illumigene® Malaria to revolutionize malaria diagnostics and set a new gold standard; with results delivered in under one hour, no need for expert training or specialist laboratory conditions, nor refrigeration or heating of materials or any specialist training.
Ken Kozak, Chief Technical Officer, Meridian Bioscience, said, “We are delighted that illumigene® Malaria has been recognized as a breakthrough in emergency treatment and point of care testing. For the first time ever, the test has the ability to bring the power and accuracy of molecular testing to many of the hardest-to-reach areas in developing countries with high-risk populations. With its high level of sensitivity, combined with a quick turnaround and simple procedure, illumigene® Malaria overcomes the key challenges that have faced malaria diagnosis in the community. In addition, the sensitivity of illumigene® Malaria allows it to be used to screen for submicroscopic infections and track the malaria reservoir in pre-elimination regions, which will be vital in the fight against malaria.”
The World Health Organization has highlighted the unmet need for screening tools to help identify submicroscopic infections, “microscopy and rapid diagnostic tests are the primary choices for diagnosing malaria in the field, but neither method is capable of detecting low density malaria infections. Since submicroscopic infections are known to contribute to the infectious disease reservoir, their significance must not be underestimated.”
Kozak continued, “We worked closely with the Centers for Disease Control and Prevention and Cheikh Anta Diop University in Senegal to develop illumigene® Malaria, which enhanced our understanding of the diagnostic barriers facing healthcare professionals in pre-elimination areas and allowed us to see the value of the test to communities in the developing world.”
LAMP based illumigene® tests are already used to diagnose other infectious diseases including C. difficile, CT/NG, Mycoplasma pneumoniae, whooping cough and the Herpes Simplex Virus, where they have proved highly accurate. illumigene® Malaria received its European CE mark of approval in January.