NANJING, China--April 10, 2026--We're thrilled to share a major milestone for Progene: our respiratory multivirus combo rapid test has officially received Class C Medical Device Registration from the Vietnam Ministry of Health. As a leading IVD innovator focused on accessible, high-quality diagnostic solutions, this approval is a huge win for our team and our expansion into Southeast Asia.
Our newly registered kit is designed to tackle the most common respiratory threats in one simple test: it delivers qualitative antigen detection for Influenza A, Influenza B, SARS-CoV-2, RSV, and Adenovirus. Built on reliable POCT technology, this RapidTest lets healthcare providers screen for multiple pathogens from a single sample, with fast results that fit perfectly in hospitals, clinics, and community health centers across Vietnam. It's a solution we built to fill a real gap in the local market: a cost-effective, easy-to-use combo test that meets the daily clinical needs of frontline workers.
Getting Class C registration in Vietnam is no small feat-it's a rigorous process that validates the safety, efficacy, and quality of our product, and we're incredibly proud to earn this recognition from the Vietnamese regulatory authorities. This approval isn't just a checkbox for us; it's the green light to bring our Respiratory testing solutions to patients and providers across the country, and to build long-term partnerships with our local distributors.
Moving forward, we're doubling down on our commitment to the Vietnamese market. We'll be working hand-in-hand with our distribution partners to deliver seamless product supply, reliable logistics, and end-to-end support-from hands-on technical training to clinical guidance and responsive after-sales service. Our goal is to make sure our partners have everything they need to successfully bring our test to every corner of Vietnam, and to strengthen local healthcare diagnostic capabilities along the way.
At Progene, we've always believed that high-quality IVD solutions should be accessible globally. This Vietnam registration is a huge step forward in that mission, and we're excited to keep innovating, expanding, and contributing to global respiratory disease prevention with our POCT and Flu testing solutions.