Noul has published a clinical paper on the performance of its malaria diagnostic product in the international journal PLOS Global Public Health, demonstrating that Noul miLab's AI-based malaria diagnostic performance was better than standard microscopy.
The current diagnostic methods for malaria, microscopy, and rapid diagnostic tests (RDTs) have low usability in the field due to a lack of infrastructure and limitations in precise diagnosis. Malaria affects 250 million people worldwide and kills more than 600,000 annually, with endemic outbreaks increasing in the United States, Europe, and Korea in recent years due to climate change, according to Noul.
The study evaluated blood samples collected from 1,650 suspected malaria patients in Gondar, Ethiopia, and Kumasi, Ghana, two malaria-endemic regions, using miLab Platform and miLab Cartridge MAL, microscopy, and RDT, respectively, and evaluated based on quantitative polymerase chain reaction (qPCR) test.
The results showed that miLab had a sensitivity of 94.3 percent and a specificity of 94 percent for P. falciparum and a sensitivity of 97 percent and a specificity of 97.6 percent for P. vivax, the two most common malaria parasites in Africa and globally, with higher sensitivity and specificity than microscopy for both species. This outperformed the gold-standard method for diagnosing malaria.
"The international community needs new technologies that surpass current malaria diagnostics' limitations. miLab is a small, fully automated device that enables AI analysis of infectious cells and is easy to use in the field. The ability to see the parasite directly on the screen increases the reliability of the diagnosis,” said Dr. Cristian Koepfli from the University of Notre Dame, U.S., who led the study. This study confirmed miLab's superior clinical performance compared to existing diagnostic methods. It is a promising technology that can meet global malaria diagnostic needs."
Kim Tae-hwan, head of Noul’s European offshoot, said, "Based on the demand for innovative diagnostic technologies that meet the gold standard methodology and the excellent performance demonstrated by reliable research results, Noul miLab is beginning to be widely used for malaria diagnosis and research purposes and is expected to realize economies of scale, especially in Africa, where the number of tests is high. “We look forward to improving miLab's competitiveness and cost-effectiveness through ongoing performance improvements in hemocytology and cervical cytology diagnostic products to contribute to the global malaria fight in various settings as a key strategic product for the international community.”
The paper is an interim result of a global clinical study funded by the RIGHT Foundation, an international health technology research fund, in 2023.
Noul plans to use the findings to communicate with malaria policymakers, including global organizations, to accelerate its entry into the public market.
Related articles
- Noul partners with US CDC, Kenya's research institute for malaria diagnosis project in Kenya
- Noul publishes AI malaria diagnostic technology studies in international journal
- Noul’s AI-based cervical cancer diagnostic platform included in US Solution Catalog
- Noul wins Saudi approval for class 3 AI-backed device to aid malaria diagnosis
