Dr Gonzalo Domingo
Senior Scientific Director, Malaria Diagnostics, PATH
Senior Commercialization Officer, PATH
An innovative partnership model is helping develop new products in the effort to fight malaria.
Creating new diagnostics for malaria requires more than just new technologies. Market forces can drive innovation—or stifle it. When prices must be low and volume is limited, companies and other commercial entities might opt out of diagnostic development and their supply.
Using an approach called a product development partnership, PATH helps reduce commercial risk for new diagnostic tools.
What is a PDP?
A PDP brings together researchers, manufacturers, academics, professionals, policy makers and donors to deliver affordable health commodities in markets that might otherwise be overlooked.
As PATH Senior Commercialisation Officer Mutsumi Metzler explains, a PDP uses the diverse experience of these partners to facilitate product development and introduction. Funded by the Foreign, Commonwealth & Development Office and the Bill & Melinda Gates Foundation, PATH uses a PDP to drive diagnostic innovations for malaria.
For malaria, we need to get a lot right to address these challenges.
Finding affordable solutions
PATH Senior Scientific Director Dr Gonzalo Domingo acknowledges two types of challenges faced in the diagnostics market: technical and commercial. “For malaria, we need to get a lot right to address these challenges,” he says. “We need the right technologies as defined by end users, the right manufacturing capabilities and the interest of manufacturers.”
Finding companies willing to work on products with low profit and market volumes is essential. PATH helps reduce the barriers to market entry, conduct market research, support regulatory approvals, and generate demand—all of which contribute to reduced risk for commercial partners.
New testing methods
A recent example of a PDP in action is the advancement of glucose-6-phosphate dehydrogenase (G6PD) tests. G6PD deficiency is an inherited condition that affects 400 million people worldwide and can cause some antimalarial drugs to negatively affect an individual. With a point-of-care test, health care workers can quickly assess whether a patient needs an alternate malaria treatment. However, getting G6PD tests to market in malaria endemic regions has relied on partnership.
“Commercially, it is a very small market, so the challenge is getting the right kind of partner and technical solution that is affordable,” says Dr Domingo. “G6PD deficiency is also prevalent in non-malaria countries, which provides additional markets beyond the treatment of malaria.”
A point-of-care G6PD deficiency test recently introduced by SD Biosensor, Inc. (South Korea) is being assessed for use in several countries in South and Southeast Asia and South America. At the same time, it is being used in non-malaria endemic regions such as the Middle East where some populations have a severe form of G6PD deficiency, providing an example where a solution arising from the PDP model can provide clinical benefits beyond its initial intended use.
As public health technologies—including diagnostics—continue to advance, the PDP model will continue to provide a strong foundation for innovation.