Marketing approval for UMT from the Nigeria NAFDAC

FyodorFyodor Biotechnologies Inc. has sponsored a study to evaluate the clinical performance of the one-step Fyodor Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the diagnosis of Plasmodium falciparum malaria in febrile patients.

A total of 1500 properly consented children and adults presenting with fever (axillary temperature ?37.5°C) or history of fever in the last 48 hours (Group 1), 250 apparently “healthy” individuals (Control, Group 2), and 50 patients with Schistosoma hematobium and Rheumatoid arthritis (Group 3), were recruited.

UMTMatched urine and fingerprick (capillary) blood samples were collected and tested using the UMT and, Binax NOW® malaria rapid diagnostic test (blood test) and thick smear microscopy, respectively. The overall agreement of the UMT results to the Binax NOW analysis and thick smear microscopy was used to establish UMT sensitivity and specificity.

The UMT showed comparable performance with blood-based tests. The UMT has the potential of expanding access to parasitological confirmation of malaria in both the public and private health sector as well as the community

As a result, Fyodor has now received marketing approval for the UMT from the Nigeria NAFDAC (food and drug agency).

According to the Principal Investigator, Wellington Oyinbo of the University of Lagos, “This is a defining moment for malaria case management and hopefully, countries will be able to meet their set national targets for parasitological confirmation of malaria. Important as well is the fact that a strip of nitrocellulose paper is able to fast-track malaria diagnosis in an otherwise weak health/diagnostic system.”

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