PacBio announced that Berry Genomics received National Medical Products Administration (NMPA) Class III approval in China for the Sequel II CNDx system paired with Berry’s clinical thalassemia assay and software—described as the first regulatory clearance for a clinical‑grade long‑read sequencer. The approval covers a diagnostic workflow to detect SNVs, indels, CNVs, structural variants and repeat expansions in a single test, addressing limitations of short‑read approaches for complex genetic disorders. PacBio and Berry positioned the clearance as a milestone for precision medicine in China, where hemoglobinopathies such as thalassemia have high incidence. PacBio executives highlighted HiFi long‑read accuracy and phasing capabilities as differentiators that can improve carrier, prenatal, newborn and rare disease testing. The approval may accelerate clinical adoption of long‑read sequencing workflows in Chinese hospitals and diagnostics labs and could alter competitive dynamics between long‑read and short‑read platforms globally. Companies and labs will watch reimbursement, clinical validation studies, and adoption across high‑incidence regions.