The E&M "Luca AI Cell Obtains European Certification for COVID-19 Diagnostic Kit"
[Asia Economy Reporter Hyunseok Yoo] THE E&M announced on the 8th that its subsidiary Luca AI Cell's five types of COVID-19 rapid antigen and antibody diagnostic kits have obtained the European In Vitro Diagnostic Medical Device Certification (CE-IVD).
The 'LUCA NK COVID-19 Antigen/Antibody Diagnostic Kit' is a next-generation product that applies the company's patented artificial cell membrane technology, significantly increasing sensitivity to enable rapid diagnosis with very small sample amounts while minimizing nonspecific reactions.
Luca AI Cell plans to enter the European market, including Italy and Turkey, under its own brand. Based on the CE certification, the company also plans to pursue certifications from the European Commission HSC (Health Security Committee), WHO EUL, and FDA.
Changdeok Kim, Director of Luca AI Cell, stated, “We recently signed export contracts for 5 million antigen diagnostic kits each with Vietnam and Thailand, and are in the process of product registration in Australia, Malaysia, Indonesia, Cambodia, and Chile. We are actively targeting not only Europe but also Southeast Asian and South American markets.”
The rapid diagnostic kits that obtained CE certification include four antigen diagnostic kits ('LUCA NK COVID-19 Ag LLB', 'LUCA NK COVID-19 Ag NP LLB', 'LUCA NK COVID-19 Ag Nasal LLB', 'LUCA NK COVID-19 Ag Saliva LLB') and one antibody diagnostic kit ('LUCA NK COVID-19 IgG/IgM LLB').
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Meanwhile, Luca AI Cell will merge with its co-founder Luca Health on the 18th. The surviving company after the merger will be Luca Health, and the dissolved company will be Luca AI Cell; after the merger, Luca Health will change its name to Luca AI Cell. CEO Seunghui Ahn said, “Through the merger of Luca Health, which holds various core technologies related to artificial cell membranes, and Luca AI Cell, which has product commercialization capabilities, we will accelerate the development of our bio business.”
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