Mico BioMed Applies for MFDS Export Approval of Monkeypox Diagnostic Kit

Clinical Trials at Senegal Pasteur Institute Confirm 100% Sensitivity and Positivity Rates

[Asia Economy Reporter Lee Gwan-joo] MikobioMed announced on the 9th that it has completed clinical trials for its monkeypox diagnostic kit and has applied for export approval from the Ministry of Food and Drug Safety.

Last month, MikobioMed conducted clinical trials of the monkeypox PCR diagnostic kit (Veri-Q MCMPx-VS) at the Pasteur Institute in Senegal. The company reported that the trials, conducted on 12 monkeypox virus positive samples and 10 negative samples, achieved both sensitivity and specificity of 100%.

A MikobioMed official explained, “Currently, it is not easy to secure actual monkeypox virus samples domestically or internationally. Through the Pasteur Institute in Senegal, with which we have established an R&D cooperation network, we successfully completed clinical trials with more samples than the Ministry of Food and Drug Safety’s required standards.”

Since 2016, MikobioMed has completed the development of the monkeypox virus diagnostic kit by carrying out two research projects commissioned by the Korea Disease Control and Prevention Agency. Additionally, in January last year, the company jointly registered a patent for the monkeypox virus diagnostic kit with the Disease Control Agency.

A MikobioMed official stated, “Following export approval from the Ministry of Food and Drug Safety, we plan to obtain the UKCA mark from the UK, where confirmed cases are high, and the European CE certification, aiming to secure market demand through prompt response.”