Mico BioMed Obtains Export Approval for Personal COVID-19 Rapid Antigen Test Kit
[Asia Economy Reporter Lee Gwan-joo] MikobioMed announced on the 11th that it has obtained export approval from the Ministry of Food and Drug Safety for a personal COVID-19 rapid antigen test kit.
The approved product, 'VERI-Q COVID-19 Ag Home Test,' has a sensitivity of 92.8% and a specificity of 99.8%, and can detect infections from the Omicron variant and the stealth Omicron variant.
MikobioMed has simultaneously applied for approval from the Australian Therapeutic Goods Administration (TGA) and expects to complete approval as early as this month. The company plans to officially enter the Australian market within the first half of the year.
A company representative stated, “Australia recommends regular rapid antigen testing in schools and businesses, so demand has not decreased yet,” and added, “We are closely consulting with local companies to supply products in line with the Australian TGA approval.”
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The Australian TGA has stricter approval standards than the World Health Organization (WHO) and applies some of the most rigorous regulations alongside the U.S. Food and Drug Administration (FDA) and European CE certification. Only three domestic diagnostic companies have obtained approval from the Australian TGA.
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