MiCo BioMed requests export of monkeypox test kit
MiCo BioMed, a manufacturer of in vitro diagnostic medical devices, said on Tuesday that it had completed the clinical trial of the monkeypox test kit and sought its export approval from the Ministry of Food and Drug Safety (MFDS).
In July, the company conducted a clinical trial of a monkeypox PCR test kit (Veri-Q MCMPx-VS) at the Institut Pasteur de Dakar in Senegal.
MiCo BioMed received 100% sensitivity (positive confirmation rate) and specification (negative confirmation rate) in testing 12 monkeypox positive and 10 negative samples. It completed the clinical trial using more samples than required by the MFDS through R&D cooperation with the Pasteur Institute in Senegal.
“We will preemptively occupy market share by obtaining export approval from the MFDS and obtaining the UKCA mark and CE certification,” a company official said.
MiCo BioMed filed the monkeypox test kit patent with the Korea Disease Control and Prevention Agency in January 2021.