GeneMind Biosciences received NMPA registration for its SURFSeq 5000 Dx high-throughput sequencer as a Category III medical device in China. The registration allows deployment for DNA and RNA sequencing across oncology, inherited disease, reproductive health, and infectious disease applications. The company said the platform is designed to generate up to 2.2 terabytes per run across two independent flow cells. It also noted that SURFSeq 5000 Dx is not approved for clinical whole-genome sequencing under the NMPA certificate. The decision underscores how Chinese sequencing hardware providers are expanding certified clinical use cases, potentially increasing competition in regulated testing workflows that require validated throughput and reproducibility.
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