PacBio said Berry Genomics received National Medical Products Administration Class III approval for the Sequel II CNDx system, marking what PacBio called the first regulatory clearance for a clinical long‑read sequencer in China and enabling a long‑read workflow for thalassemia and complex variant detection. Separately, Chinese authorities moved to lift an earlier export ban on Illumina’s sequencers and confirmed regulatory changes that ease access to sequencing instruments starting Nov. 10, though Illumina will remain on an 'unreliable entities' list requiring approvals. The twin developments shift the competitive landscape for sequencing suppliers in China and signal regulatory openness to clinical applications of long‑read sequencing. Clarification: long‑read sequencing provides extended DNA read lengths that can resolve structural variants and complex genomic regions not easily detected by short‑read platforms.
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