PacBio (PACB) announced that, through its long-standing partnership with Berry Genomics, the Sequel II CNDx system has received Class III Medical Device Registration approval from the National Medical Products Administration, NMPA, in China. This marks the first regulatory clearance of a clinical-grade long-read sequencer, a milestone led by Berry Genomics. “PacBio’s mission is to enable the promise of genomics to better human health,” said Christian Henry, President and Chief Executive Officer of PacBio. “China’s regulatory approval of Sequel II CNDx reflects not only the quality and performance of HiFi sequencing, but also its readiness to improve clinical outcomes on a global stage.”
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