Project leaderAlfredo Mayor
Participating organizationsISGlobal, Foundation for Innovative New Diagnostics (FIND)
To develop a serological test to monitor recent exposure of pregnant women to the Plasmodium falciparum parasite, which causes malaria. Use of this serological test will help measure the impact of eradication efforts to completely interrupt transmission of the parasite.
ISGlobal has investigated the use of serological tests in malaria and the potential of using pregnant women as a sentinel group in malaria vigilance, as there is evidence that the prevalence of malaria in these cases is comparable to the prevalence in the population of children in a community. The Foundation for Innovative New Diagnostics (FIND) is processing and funding the patent application, submitted in the United States in June 2017, and the PCT, expected to come one year later, with exclusive sublicensing rights.
Most significant challenges
It is quite a challenge to get the product to market and this will require the involvement of international stakeholders in global health, including WHO, PATH, USAID, Global Fund to Fight AIDS, TB and Malaria and the Bill and Melinda Gates Foundation, as well as the private sector. With this aim, ISGlobal and FIND have agreed to draft a preliminary business plan to start contact with the international diagnostics industry and gage commercial interest in the test while applying for the patent.
The proof of concept has yielded positive results, but no clinical trials have yet been done. One patent application has been submitted. One element that sets this serological test apart is its application in prenatal appointments, which cuts the cost of implementing epidemiological vigilance systems that are more complex to organize and fund, as well as national malaria surveys.
In terms of exploitation, it is expected to be rolled out in both the public and private sectors in low-income endemic countries.