PacBio, In Partnership With Berry Genomics, Receives Class III Medical Device Registration From China's NMPA, Enabling High-Accuracy Long-Read Genomic Testing For Thalassemia And Other Complex Genetic Disorders

PacBio (NASDAQ:PACB), developer of the world's most advanced sequencing technologies, today 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 world's first regulatory clearance of a clinical-grade long-read sequencer, a milestone led by Berry Genomics that signals a new era for precision medicine and high-accuracy genomic testing in China.

High-incidence genetic disorders such as thalassemia often involve complex variant types that are difficult or impossible to detect using short-read sequencing.

With the Sequel II CNDx system, clinicians can now access a complete picture of the genome in a single test—capturing single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), structural variants (SVs), and repeat expansions with exceptional accuracy.

When paired with Berry's newly approved clinical thalassemia assay and software system, this approval delivers the first end-to-end long-read sequencing workflow for China's hospitals and diagnostic laboratories, optimized for carrier, prenatal, newborn, and rare disease testing.