[Asia Economy Reporter Hyunseok Yoo] A-Root's exclusive overseas sales partner, DNA Link, has obtained European certification (CE) for its novel coronavirus (COVID-19) rapid diagnostic kit following export approval from the Ministry of Food and Drug Safety. This development is expected to mark the official start of A-Root's COVID-19 diagnostic kit exports. DNA Link has already completed product registration for the rapid diagnostic kit with the U.S. FDA and is currently undergoing approval, with expectations to receive U.S. FDA approval soon after the European CE certification.
A-Root announced on the 8th that DNA Link's COVID-19 rapid diagnostic kit has obtained European certification (CE).
With this European certification, A-Root can export not only to Europe but also to most countries overseas that have adopted the European certification. Supply requests for the rapid diagnostic kits have significantly increased from over 20 countries in the U.S., Asia, and the Middle East. A-Root is currently negotiating supply agreements with key stakeholders, focusing on Asia and the Middle East, where it holds exclusive sales rights. The supply volume under discussion so far amounts to 27 million kits.
An A-Root representative stated, "The rapid diagnostic kit developed by DNA Link tests for 'multiple antibodies' rather than a single antibody, which has led to greater overseas demand. Preclinical results verified an accuracy rate of 93%, and the kit can determine infection status within 10 minutes, attracting significant interest from key officials in various countries."
He added, "A-Root has already secured exclusive sales rights in Asia and the Middle East, and through collaboration with GTG Wellness, which holds exclusive rights in Africa and other regions, sample provision to agents has been completed, and supply volumes and pricing are under negotiation. Considering the volumes currently being discussed, once the country-specific accuracy tests conducted with samples are completed, orders from each country are expected to surge, resulting in substantial export volumes."
DNA Link's IgG/IgM simultaneous antibody diagnostic kit can measure both IgM and IgG antibodies in a single kit without the need for a 'plasma separation' process from blood. This product offers excellent speed and convenience, and A-Root expects it to demonstrate differentiated competitiveness in the diagnostic kit market.
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