On February 11, the GCTSEQ-2000 gene sequencer, launched by Genecast (Taizhou) Biotechnology Co., Ltd.—an in vitro diagnostic production base under the umbrella of Genecast Biotechnology—has officially received the Medical Device Registration Certificate (No. 20253220358) from China’s National Medical Products Administration (NMPA), authorizing its clinical use in the domestic market. This milestone signifies that Genecast Biotechnology has achieved full-process coverage with its one-stop in-hospital solution, spanning from the gene sequencing library preparation system (Jiangsu Device Registration No. 20222221650) to gene sequencing reagents (National Device Registration No. 20213400151), the gene sequencer (National Device Registration No. 20253220358), and gene detection data management software (Jiangsu Device Registration No. 20212211534)—all compliant and secure.
The newly approved GCTSEQ-2000 gene sequencer is a domestically developed sequencing platform, co-developed by Genecast Biotechnology and MGI Tech. This product utilizes DNBSEQTM technology and a brand-new flow cell system, enabling flexible support for multiple sequencing modes. With its optimized optical and biochemical system design, it can complete the entire sequencing process in a shorter time, delivering a more streamlined and efficient sequencing experience for users.
The GCTSEQ-2000 Gene Sequencer features highly flexible throughput adjustment capabilities, delivering a throughput range of 55-1440Gb per run. It supports simultaneous processing of one to two flow cells per run, while allowing independent runs with different flow cell specifications, including the small FCS flow cell and large FCL flow cell. This design significantly enhances experimental efficiency and meets diverse research needs.
Moreover, the sequencer is compatible with various sequencing read lengths, demonstrating stable performance across both short-read and long-read sequencing. With its exceptional versatility, it provides comprehensive coverage for diverse sequencing applications—delivering reliable data support for both basic genomic research and clinical precision diagnostics. Thanks to these advantages, this model has gained widespread popularity in sequencing laboratories worldwide and becoming a preferred platform for many research and clinical institutions.