Green Cross MS Receives Approval for COVID-19 Rapid Antigen Test Kit Use

GC Green Cross MS's COVID-19 Antigen Test Kit 'Genedia W COVID-19 Ag' (Provided by GC Green Cross MS)

[Asia Economy Reporter Chunhee Lee] GC Green Cross MS's COVID-19 rapid antigen test kit has received approval for use.

GC Green Cross MS announced on the 2nd that it has obtained domestic use approval from the Ministry of Food and Drug Safety for its COVID-19 rapid antigen test kit, ‘GENEDIA W COVID-19 Ag’.

This product is one of the ‘GENEDIA’ series, GC Green Cross MS's main export items. It is an antigen test kit that uses antigen-antibody binding reactions to diagnose COVID-19 infection on-site within 10 minutes. Using nasopharyngeal specimens, it allows visual confirmation of infection in early patients without any additional equipment.

The product shows a sensitivity of up to 94% in patients within 7 days of symptom onset. Green Cross MS confirmed reactivity to the Alpha (UK variant) and Beta (South Africa variant) viruses through actual virus tests conducted by the Korea Research Institute of Chemical Technology, and also verified recombinant protein reactivity to the Gamma (Brazil variant) and Delta (India variant) variants in its own laboratory tests.

Previously, in August last year, it received export approval and is currently exporting the product to countries including Germany, Italy, and Brazil.

Ahn Eun-eok, CEO of GC Green Cross MS, said, “After completing verification for all confirmed variant viruses, we applied for domestic approval of this product. With the recent surge in confirmed cases domestically and internationally due to the spread of COVID-19 variants, we expect rapid sales growth in the global COVID-19 test kit market following this domestic use approval.”