Shanghai-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced significant regulatory milestones in the United Kingdom. The company’s monkeypox virus antigen detection kit, utilizing a colloidal gold method, has been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for marketing. Additionally, its novel coronavirus (2019-nCoV) antigen detection kit, also employing the colloidal gold method, has secured a five-year Coronavirus Test Device Approval (CTDA) in the country. This marks a transition from emergency use to long-term utilization.
The approvals underscore Hotgen Biotech’s commitment to providing reliable diagnostic solutions for emerging and prevalent infectious diseases. The MHRA’s endorsements further validate the company’s expertise in developing high-quality antigen detection kits, which are essential tools in the global fight against viral outbreaks.-Fineline Info & Tech
