Amid escalating global public health demands, OrientGene, leveraging its profound expertise in infectious disease diagnostics, is strategically expanding its footprint in the respiratory testing market through breakthroughs in multiplex detection technologies, the development of a global product portfolio, and the expansion of market channels. 

From professional healthcare institutions to at-home self-testing scenarios, and from pathogens such as COVID-19 and influenza to avian influenza, OrientGene is delivering precise and efficient solutions for global public health systems by advancing technological innovation and establishing a globally recognized certification framework. 

Gaining International Recognition

Recent research published by Emory University, a leading U.S. academic institution, has drawn significant industry attention. The study highlighted the exceptional performance of OrientGene’s Healgen® COVID-19/Flu A&Flu B Antigen Triple Test and H5N1 diagnostic reagents. 

The Healgen® COVID-19/Flu A&Flu B Antigen Triple Test demonstrated sensitivity exceeding 90% and specificity above 99%. Notably, in testing 2024 H5N1 samples, the Healgen® Triple Test exhibited 2 to 20 times higher sensitivity compared to other lateral flow assay (LFA) products evaluated in the study, with a detection limit approaching that of molecular diagnostic tests. 

A landmark achievement, the Healgen® Triple Test became the first multiplex assay to receive FDA De Novo certification, prompting the FDA to establish a new regulatory classification for such products. The FDA officially announced this milestone on its website, and ABC News recognized it as one of the “Top Five Breakthroughs in U.S. Medicine in 2024”. 

Emory University’s study also revealed that among commercially available influenza tests evaluated, Healgen’s H5N1-specific rapid antigen test was the only one capable of accurately distinguishing avian influenza from other influenza A subtypes. Currently, there are few rapid and specific H5N1 diagnostic tests available globally, making Healgen’s H5N1 test a critical tool for public health agencies in managing highly pathogenic avian influenza outbreaks. 

In April, OrientGene achieved another milestone when its COVID-19/Flu A&Flu B/RSV/Adenovirus Antigen Combo Test (Colloidal Gold) and Flu A&Flu B/RSV/Adenovirus Antigen Combo Test (Colloidal Gold) obtained EU IVDR certification. This further validates the company’s R&D capabilities and quality management in respiratory multiplex diagnostics, providing Europe with an efficient and convenient solution for multi-pathogen surveillance. 

Building the World’s Most Comprehensive Respiratory Testing Portfolio

From single-pathogen tests to advanced multiplex assays, OrientGene is strengthening its respiratory testing product matrix with a diversified approach. 

Beyond the aforementioned products, OrientGene has secured FDA 510(k) clearance for tests detecting COVID-19 and Group A Streptococcus. Additionally, multiple respiratory diagnostic products (professional and self-test versions) have received EU IVDR certification, including: 

- Group A Streptococcus test

- COVID-19/Flu A&Flu B Antigen Triple Test

- Flu A/Flu B/RSV/Adenovirus Antigen Test

- COVID-19/Flu A/Flu B/RSV/Adenovirus Antigen Test

Furthermore, OrientGene and its subsidiaries offer diagnostic solutions for respiratory pathogens such as Mycoplasma pneumoniae, human metapneumovirus (hMPV), and pertussis, utilizing platforms like Immunology, nucleic acid testing, and Quantum-Beads Flowcytometry. Several of these products have already obtained EU certification. 

Dual Strategy: Professional use + Self Testing

Unlike traditional IVD companies focusing solely on healthcare settings, OrientGene adopts a **dual-track strategy**, advancing both professional and self-test product registrations. Its at-home tests are now available in major U.S. retail chains such as CVS and Walgreens, expanding accessibility far beyond conventional medical channels. 

“OrientGene capitalizes on its R&D strengths in infectious disease diagnostics, particularly respiratory infections, by prioritizing the development, certification, and commercialization of professional and at-home testing solutions,” said Fang Xiaoliang, General Manager of OrientGene. In recent years, the company has secured 126 professional and self-test certifications across the U.S., Europe, Saudi Arabia, New Zealand, and Malaysia, covering over 10 respiratory pathogens including COVID-19, influenza A/B, monkeypox, and RSV—solidifying its position as a global leader in comprehensive respiratory diagnostics. 

From FDA De Novo milestones to EU IVDR breakthroughs, and from avian influenza-specific detection to the democratization of self-testing, OrientGene is reshaping the global IVD landscape through technological innovation. As public health awareness rises worldwide, the company’s “all-scenario, multi-technology, globalized” respiratory testing framework is emerging as a pivotal force in advancing public health systems.