Introducing the first non-blood malaria test

THE CHALLENGE

Malaria is one of the world’s deadliest and most underdiagnosed diseases. According to the World Health Organisation, 216 million cases and 445 000 deaths are registered annually, 90% of them in Africa and more than half in African children under 5.

To be diagnosed, people living in malaria-endemic areas who develop a fever – the earliest symptom of the disease – must travel to a brick-and-mortar clinic for a malaria blood test. For most, this is not an option because the nearest health centre is simply too far away. Many others are discouraged by the cost of the trip and the wait of up to one day for a result. Also, poorly resourced health facilities struggle to offer blood-based malaria testing due to its cost and the skills required to perform it. As a result, many people don’t get tested and end up managing their fevers based on guesswork.  

THE SOLUTION

The biotech start-up Fyodor Biotechnologies has developed an innovative solution that addresses these barriers to diagnosis. Its Urine Malaria Test (UMT) is the first non-invasive alternative to blood-based diagnostics which can be obtained without a prescription from a pharmacy and administered anywhere, including at home. Sold at a wholesale cost of USD 1.40, this dipstick test uses novel recombinant monoclonal antibodies to detect parasite proteins from the most common type of malaria, plasmodium falciparum, in the urine of febrile patients.

The test process is simple: the user dips the UMT strip in a container in which a urine sample has been collected, lets it stand for 25 minutes and reads the result. Two lines across the strip indicate malaria, one line indicates fever but no malaria. Although the test sometimes gives a false negative or false positive result, its overall accuracy exceeds the World Health Organisation standard of 75%, putting it on par with the commercially available blood-based rapid test kits commonly used in low-resource settings. The UMT is also particularly good at detecting malaria in children under 5, who are at greatest risk of dying from the disease without timely treatment.

IMPACT ACHIEVED SO FAR?

Following a clinical trial that began in late 2013, the UMT received approval from the responsible authorities in Nigeria and Liberia in 2016. In 2017 Fyodor tested consumer demand in these markets by distributing 200 000 tests to pharmacies in Nigeria and another 20 000 in Liberia. Within six months, all had been sold without any marketing effort. After refining the product and production process, the company started commercialising the UMT at full scale in early 2019.