Senizen, M-Pox Diagnostic Kit Obtains MFDS Export Approval... "Knocking on the African Continent"

Senizen, a total food safety solution company, announced on the 17th that it has obtained export approval from the Ministry of Food and Drug Safety (MFDS) for the Mpox (MPOX, Monkeypox) virus test diagnostic kit ‘Genelix™ Monkeypox Real-time PCR Detection Kit.’

The approved diagnostic kit is an in vitro diagnostic medical device that identifies monkeypox virus DNA from skin lesion specimens of patients showing symptoms of monkeypox virus infection. This device can confirm infection status within 90 minutes using viral nucleic acid (Viral DNA) extracted from the specimen. Senizen had already completed technology development and secured patent registration in May 2023, gaining recognition for its technological capabilities.

Mpox is an endemic disease in Central and West Africa, characterized by acute fever, headache, muscle pain due to viral infection, and accompanied by vesicular rash symptoms. In 2022, it spread across the Americas and Europe, prompting the World Health Organization (WHO) to declare an international public health emergency of international concern (PHEIC), the highest level of health alert. The emergency was lifted as the spread subsided. However, this year, a new variant of Mpox with a faster transmission rate and relatively higher fatality rate has spread mainly in Africa, leading WHO to declare the Mpox PHEIC for the second time in 1 year and 4 months in August.

According to WHO’s situation report, from January to the end of September this year, there were 6,753 confirmed cases of Mpox and 996 deaths in Africa. Additionally, suspected cases reached 35,525.

A Senizen official stated, “With this MFDS export approval, it is now possible to sell Mpox diagnostic kits to global countries,” adding, “We plan to prioritize securing the African market to respond to the globally spreading Mpox virus.”

This content was produced with the assistance of AI translation services.