Core Viewpoint - The recent EU IVDR certification of the new combined antigen detection kit for COVID-19, influenza A and B, respiratory syncytial virus, and adenovirus by Dongfang Bio signifies a major advancement in the company's capabilities in respiratory virus detection and enhances its international recognition in the field [1][2] Group 1: Product Development and Certification - Dongfang Bio's newly developed antigen detection kit has received EU IVDR certification, indicating a higher regulatory standard compared to the previous IVDD certification, which enhances the product's legal status and compliance requirements [1] - The detection kit allows for the qualitative and differential detection of five viruses from a single nasal swab sample within 15 minutes, meeting the rapid testing needs during high incidence periods of respiratory diseases [1] Group 2: Market Position and Global Expansion - Dongfang Bio has established a strong presence in the respiratory infectious disease detection market, having previously obtained various IVDR and FDA certifications for its products in Europe and the United States [2] - The company's COVID-19 and influenza combination detection product has been recognized as one of the "Top 5 Medical Breakthroughs of 2024" by ABC News and is currently available in major retail pharmacies like Walgreens [2] - Dongfang Bio is accelerating its global expansion with local production bases in the US, UK, and Canada, which supports scalable production and aligns with the demand for efficient diagnostic solutions in the post-pandemic era [2]