MiCo BioMed, an in-vitro diagnostic medical device maker, said Tuesday that it completed the clinical trial of the monkeypox testing kit and applied for its export approval to the Ministry of Food and Drug Safety (MFDS).

MiCo BioMed has applied to export a monkeypox testing kit to the Ministry of Food and Drug Safety.
MiCo BioMed has applied to export a monkeypox testing kit to the Ministry of Food and Drug Safety.

In July, the company conducted a clinical trial of a monkeypox PCR testing kit (Veri-Q MCMPx-VS) at the Institute Pasteur de Dakar in Senegal.

MiCo BioMed received 100 percent on sensitivity (positive confirmation rate) and specification (negative confirmation rate) in the trial conducted on 12 monkeypox positive and 10 negative samples. It completed the clinical trial using more samples than demanded by the MFDS through R&D cooperation with Senegal’s Pasteur institute.

“We will preemptively occupy market share by winning export approval from the MFDS and obtaining the UKCA mark and CE certification,” a company official said.

MiCo BioMed registered the patent for the monkeypox testing kit with the Korea Disease Control and Prevention Agency in January 2021.

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