Recently, Orient Gene’s independently developed COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)—a colloidal gold-based antigen combination test for SARS-CoV-2, Influenza A/B, Respiratory Syncytial Virus (RSV), and Adenovirus (ADV)—successfully passed EU review and obtained the IVDR (In Vitro Diagnostic Regulation) certification. This milestone reaffirms Orient Gene’s R&D capabilities and quality management in multiplex respiratory virus testing, providing Europe with an efficient and convenient solution for multi-pathogen surveillance.

The COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test is an immunochromatographic in vitro diagnostic kit designed for the qualitative detection and differentiation of SARS-CoV-2, Influenza A/B, RSV, and Adenovirus antigens in nasal swab specimens collected within seven days of symptom onset. With a single sample, it simultaneously screens for five major respiratory viruses, offering flexibility to meet the demands of rapid clinical testing. The kit is user-friendly, highly accurate, and delivers results within 15 minutes, making it ideal for high-frequency testing amid recurrent respiratory infections.

The EU’s regulatory landscape has grown increasingly stringent, with IVDR certification imposing higher legal and compliance standards compared to the previous IVDD framework. To meet these requirements, Orient Gene conducted extensive analytical performance evaluations, cross-reactivity studies, stability testing, and large-scale clinical trials in Europe to ensure product efficacy and safety. This achievement underscores the company’s commitment to high standards and rigorous quality control.

Moving forward, Orient Gene will leverage its leading R&D and manufacturing expertise in respiratory diagnostics to further expand in the European and American markets. Prior milestones include:

• EU Market: IVDR certifications for COVID-19 professional/self-tests, COVID-19/Flu A/B combo tests (professional/self-tests), and Strep A professional tests.

• US Market: FDA approvals for COVID-19, COVID-19/Flu A&B combo tests, RSV tests, and Strep A tests.

  
  

Orient Gene’s respiratory infection test kits have gained widespread acclaim in premium markets, particularly its FDA De Novo-authorized COVID-19/Flu A&B combo test, celebrated for its high sensitivity and specificity. The FDA highlighted the innovation in a LinkedIn news feature, while ABC News named it one of "America’s Top 5 Medical Breakthroughs of 2024."

Orient Gene has established localized production facilities in the US, UK, Canada, and other regions, enabling scalable manufacturing to meet global demand.