New test being developed to enable faster, more tailored treatment for malaria. Over 200 million cases of malaria annually.
Global Innovation Network Ltd (“GIN”), a private Finland-based developer and manufacturer of rapid diagnostic test production and medical device manufacturing solutions, today announces the award of a 500 000 € grant from the European Commission’s Framework Programme 7 to help fund a three year project (DIAGMAL) to develop a new rapid molecular diagnostic test for malaria. This test will be used directly on fresh blood samples to confirm the presence of Plasmodium parasites, the infectious agent that causes malaria. There are currently no rapid molecular tests for the Plasmodium parasite on the market.
Malaria is a life-threatening disease with around 3.3 billion people, half of the world’s population, at risk(1). In 2010, there were thought to be around 219 million cases of malaria and an estimated 660,000 deaths(1). Malaria is caused by Plasmodium parasites which are transmitted to humans through bites from infected Anopheles mosquitoes. There are five types of Plasmodium parasite species that cause malaria in humans, the most common being Plasmodium falciparum and Plasmodium vivax. Different therapeutic strategies are required to treat each of these parasites.
The new test uses the technique Polymerase Chain Reaction (“PCR”) to amplify the DNA from the Plasmodium parasite to such an extent that its presence can be detected on an easy-to-use immunoassay strip. This PCR-based test is inexpensive, rapid, and up to 100 times more sensitive than the widely used immunodiagnostic assays. As the test can be used directly on fresh blood samples, no processing of blood is required, allowing results to be delivered in as little as 60 minutes.
GIN will develop a manufacturing solution for the new test. High volume-high quality manufacturing is essential to be able to provide the test for its intended use. GIN’s automated robotic production solution will ensure high yield in the production which is one of the key factors to be able ensure the availability of the new test in all key markets.
The project will be led by Dr. Henk Schallig of the Royal Tropical Institute in Amsterdam. Forsite Diagnostics in UK, Q-Bioanalytic GmbH in Germany and the Global Innovation Network Ltd in Finland are collaborating partners in the project which started on 1 September 2013.