MiCo BioMed, an in-vitro diagnostic medical device maker, said it obtained the Ministry of Food and Drug Safety’s export approval for its monkeypox test kit on Wednesday.
MiCo BioMed developed the test kit, called “'Veri-Q MCMPx-VS,” through the Korea Disease Control and Prevention Agency’s 2016 research program. The two jointly registered the patent of the monkeypox diagnostic kit.
In July, the company conducted a clinical trial of the test kit at the Institute Pasteur de Dakar (IPD) in Senegal.
According to MiCo BioMed, the trial results showed that the kit demonstrated 100 percent sensitivity and specificity in 12 monkeypox positive and 10 negative samples.
The company said it would push to supply the kit to the African region first, via IPD.
“The IPD in Senegal, which cooperated for the clinical trial, acts as a control tower for the prevention, diagnosis, and treatment of infectious diseases in West Africa,” an official at MiCo BioMed said.
By working with the IPD, the company will supply the monkeypox diagnostic kit to the African region through international health organizations such as the Coalition for Epidemic Preparedness Innovations (CEPI), he added.
As the U.S. Department of Health and Human Services on Sept. 7 granted emergency use authorization (EUA) for a smallpox diagnostic kit, the company will utilize its U.S. subsidiary, MiCo BioMed USA, to apply for EUA to the FDA, the official explained.