GUANGZHOU—DaAn Gene Co., Ltd, a subsidiary of Sun Yat-sen University based in China (SHE: 002030), has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its Monkeypox virus nucleic acid detection kit, which utilizes the fluorescence PCR method. This development is significant as it pertains to the in vitro qualitative detection of the Monkeypox virus and is expected to be used for sample testing in suspected cases and for diagnostic or differential diagnostic purposes for individuals who may have been infected with the virus.
The Monkeypox virus has garnered global attention, especially after the World Health Organization issued its highest level alert in July 2022 for the second time, highlighting the importance of reliable diagnostic tools. The approval of DaAn Gene’s detection kit comes at a critical time, as it provides a specific and sensitive method for identifying the virus.
Previously, DaAn Gene has demonstrated its commitment to advancing diagnostic capabilities, with multiple home-grown monkeypox virus detection products having already received CE marks in Europe. The company’s track record in developing reliable and effective diagnostic solutions positions it well to contribute to the global effort in managing the Monkeypox health challenge.- Flcube.com
