PacBio has secured Class III Medical Device Registration approval from China’s National Medical Products Administration for its Sequel II CNDx long‑read sequencing platform, the first clinical‑grade long‑read system cleared for use in Chinese hospitals and diagnostic laboratories.
The approval enables clinicians to perform comprehensive genomic testing—including single‑nucleotide variants, insertions and deletions, copy‑number variants, structural variants, and repeat expansions—in a single run, providing a high‑accuracy, complete view of the genome that is difficult to achieve with short‑read technologies.
The clearance comes amid a shift in the Chinese genomics market following the March 2025 import ban on Illumina DNA sequencers, creating an opening for alternative platforms. PacBio’s partnership with Berry Genomics, which has an established local presence, positions the company to deliver end‑to‑end long‑read sequencing workflows in China.
PacBio’s financial performance in recent quarters shows strong growth. In Q3 2023 revenue reached $55.7 million, up 72% from $32.3 million in Q3 2022, and Q4 2023 revenue was $58.4 million, up 113% from $27.4 million in Q4 2022. The company expects the new approval to accelerate adoption of its clinical genomics services in China, potentially boosting future revenue.
PacBio is scheduled to report its earnings on November 5 2025, the day after the approval announcement. Management highlighted the approval as a key milestone in expanding its long‑read technology into high‑value clinical applications and strengthening its competitive position in the precision‑medicine market.
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