NEW YORK – Chinese sequencing tech company GeneMind Biosciences said earlier this month that its single-molecule DNA sequencer, GenoCare 1600 (originally developed by Direct Genomics), has been approved by China's National Medical Products Administration (NMPA) for clinical and diagnostic applications.
According to the NMPA approval letter, dated July 13, 2022, the sequencer is approved for in vitro noninvasive prenatal testing to detect Down syndrome, Edwards syndrome, and Patau syndrome. The device is not approved for clinical human whole-genome sequencing.
The NMPA approval is "a strong proof of GeneMind's single-molecule sequencing technology and product service capabilities," the company's cofounder and CEO Qin Yan said in a statement on WeChat.
According to GeneMind, the GenoCare 1600 platform, which is based on surface-restricted fluorescent sequencing (SURF-seq) and uses total internal reflection (TIRF) microscopy to identify the fluorescent signal of bases, promises a sequencing-by-synthesis approach "that delivers speed, flexibility, high accuracy, and low cost."
With features such as PCR-free operation and automatic analysis, the GenoCare 1600 sequencer "greatly simplifies" the gene detection process, GeneMind said, significantly reducing cost and turnaround time.
Founded in 2012 and headquartered in Shenzhen, China, GeneMind said that in addition to the GenoCare 1600, it has launched a high-throughput sequencing platform named GenoLab M.
Direct Genomics originally developed the GenoCare platform, using technology devised by Helicos BioSciences. The company ousted its founder, He Jiankui, in 2019 after he edited the germline genomes of twin girls as embryos. It was unclear as of press time whether Direct Genomics changed its name to GeneMind or whether it transferred its technology to that firm.