By Fineline Cube 
China‑based DaAn Gene Co., Ltd. (SHE: 002030), a research arm of Sun Yat‑sen University, announced that its Human Immunodeficiency Virus Type 1 (HIV‑1) DNA Diagnostic Kit (PCR‑Fluorescence Probe Method) has received marketing approval from the National Medical Products Administration (NMPA) (registration no. 20253401805).
Product Highlights
- Ultra‑Sensitive Detection – The kit directly amplifies HIV‑1 DNA integrated into the host genome, enabling early diagnosis of occult infections.
- Broad Clinical Utility – Ideal for cases with indeterminate or negative antibody tests yet high clinical suspicion of infection.
- First‑Mover Advantage – DaAn Gene is the first Chinese company to hold licences for both HIV‑1 DNA and RNA nucleic‑acid test kits, marking a milestone in AIDS laboratory diagnostics.
Regulatory Milestone
- NMPA Approval – Confirms compliance with stringent safety, efficacy, and quality standards required for in‑house HIV testing.
- Market Access – The kit can now be marketed nationwide, opening avenues for hospitals, private labs, and community health centres.
Market Impact
- Diagnostic Landscape – The availability of a single‑platform DNA kit simplifies workflows, reduces turnaround time, and improves early detection rates.
- Competitive Edge – DaAn Gene’s integrated DNA‑RNA testing portfolio positions it ahead of domestic competitors lacking comprehensive HIV testing solutions.
- Public Health Benefit – Earlier detection translates to earlier treatment initiation, potentially curbing transmission and improving patient outcomes.
Forward‑Look
DaAn Gene plans to leverage the NMPA approval to expand its product line, including multiplex panels for other viral pathogens, and to pursue international regulatory submissions in the coming years.-Fineline Info & Tech