PacBio Supports Berry Genomics in Achieving First Regulatory Approval for Clinical Long-Read Sequencing in China

Rhea-AI Summary

PacBio (NASDAQ: PACB) said the Sequel II CNDx system gained NMPA Class III medical device approval in China through its partner Berry Genomics on Nov 4, 2025.

This marks the first regulatory clearance of a clinical-grade long-read sequencer worldwide and enables Berry to offer an end-to-end long-read HiFi sequencing workflow in China, initially targeting thalassemia carrier, prenatal, newborn, and rare-disease testing. The system delivers long reads (≥20 kb) with high accuracy, detecting SNVs, indels, CNVs, SVs, repeat expansions and enabling phasing in a single run. PacBio and Berry plan to expand clinical assays and support deployment with AI analysis and local partnerships to reduce turnaround times and increase diagnostic yield.

Positive

• NMPA Class III approval granted for Sequel II CNDx system
• First worldwide regulatory clearance for clinical long-read sequencer
• Initial clinical offering approved for thalassemia testing
• Detects SNVs, indels, CNVs, SVs, repeat expansions in one run
• Read lengths of 20 kb+ with high-accuracy HiFi sequencing
• Berry authorized to deploy long-read platform in China clinical labs

Negative

• Initial approved workflow limited to thalassemia assays at launch
• Clinical deployment authorized via Berry partnership, not direct PACB rollout

Insights

Regulatory and Clinical Genomics Analyst

China NMPA Class III approval for the Sequel II CNDx enables clinical long‑read HiFi sequencing for thalassemia and marks a first-of-its-kind clearance.

By securing Class III Medical Device Registration from the NMPA, the Sequel II CNDx becomes an authorized clinical long-read sequencing platform in China when used with Berry Genomics’ approved thalassemia assay and software. This creates a turnkey, end-to-end workflow for carrier, prenatal, newborn, and rare-disease testing that reports SNVs, indels, CNVs, SVs and repeat expansions from a single test, potentially improving diagnostic completeness for complex variant types compared with short-read approaches.

Adoption depends on laboratory validation, clinician acceptance, reimbursement pathways and Berry’s distribution and support capability; regulatory approval alone does not guarantee rapid uptake. There is uncertainty about volume, price, and how widely hospitals and diagnostic labs will integrate the system into routine practice, and any operational or software issues could slow deployments.

Concrete items to watch include Berry Genomics’ rollout speed across hospitals and diagnostic labs in China, publication or internal data demonstrating clinical diagnostic yield for thalassemia, and approvals or assay expansion timelines for the other assays mentioned; monitor developments over the next 6–18 months for measurable adoption and additional regulatory clearances.

NMPA approval on the Sequel II CNDx system enables clinicians in China to harness PacBio HiFi sequencing for challenging conditions, with initial offering for thalassemia

MENLO PARK, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- 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.

“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.”

The Sequel II CNDx system leverages PacBio’s proprietary Single Molecule, Real-Time (SMRT^®) technology, the only sequencing technology capable of delivering both high accuracy and long read lengths of 20 kb and greater. Unlike traditional approaches to thalassemia testing, HiFi sequencing allows each DNA molecule to be analyzed directly, discriminating highly homologous sequences while capturing single nucleotide variants (SNVs), insertions and deletions (indels), copy number variants (CNVs), structural variants (SVs), and enabling phasing in a single run.

“We are proud to bring PacBio’s HiFi sequencing technology into clinical practice,” said Dr. Aiping Mao, Vice Director of R&D at Berry Genomics. “This approval validates our shared vision of providing clinicians with the most accurate and comprehensive view of the genome. We plan to expand this capability to more clinical assays like congenital adrenal hyperplasia, fragile X syndrome, spinal muscular atrophy, Duchenne muscular dystrophy, and other complex single-gene disorders and panels. All these assays also work very well on the newly launched benchtop Vega HiFi sequencer in clinical research applications.”

The NMPA approval represents advancement for China’s clinical genomics ecosystem. With this approval, Berry Genomics becomes the first company worldwide authorized to deploy a long-read sequencing platform in clinical settings, empowering laboratories to conduct in-country testing with reduced turnaround times and higher diagnostic yield as compared to existing technology. This achievement reflects PacBio’s continued commitment to collaborate with regional leaders to expand access to comprehensive, highly accurate sequencing. As demand for comprehensive genomic testing continues to grow, PacBio remains focused on expanding the clinical utility of HiFi sequencing. Through partnerships with local institutions and investments in AI-powered analysis, PacBio is committed to lowering barriers to adoption and enabling clinicians worldwide to deliver more precise answers to patients and families.

About Berry Genomics

Founded in May 2010, Berry Genomics is a leading company in clinical genomics and life science in China. Berry Genomics is dedicated to research, development and commercialization of genetic test technologies in clinical applications. Berry Genomics aims to assist accurate diagnosis of diseases throughout the full human life circle, and to improve human health.

As a company with strong R&D capability, Berry Genomics pioneered the first NGS-based genetic test, NIPT, in China back in 2010. The company currently provides NGS-based tests for many genetic diseases and cancer from preconception to adulthood.

Berry Genomics has around 1500 employees dedicating to developing products and providing services for over 4000 organizations and facilities home and abroad, including hospitals, research institutions, universities and corporations. Berry Genomics has been listed on A-share market in China since 2017 under the stock code: 000710.

About PacBio

PacBio (NASDAQ: PACB) is a premier life science technology company that designs, develops, and manufactures advanced sequencing solutions to help scientists and clinical researchers resolve genetically complex problems. Our products and technologies, which include our HiFi long-read sequencing, address solutions across a broad set of research applications including human germline sequencing, plant and animal sciences, infectious disease and microbiology, oncology, and other emerging applications. For more information, please visit www.pacb.com and follow @PacBio. 

PacBio products are provided for Research Use Only. Not for use in diagnostic procedures. 

Forward-Looking Statements:
This press release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are forward-looking statements, including statements relating to advantages, or quality or performance of, or benefits or expected benefits or advantages of using, PacBio products or technologies, such as using HiFi sequencing for challenging conditions; new era for precision medicine and genomic testing in China; using PacBio technology to access a complete picture of the genome in a single test; vision to provide clinicians with the most accurate and comprehensive view of the genome; seeking additional approvals from the NMPA; commitments to collaborate with leaders to expand access to sequencing; and other future events. You should not place undue reliance on forward-looking statements because they are subject to assumptions, risks, and uncertainties and could cause actual outcomes and results to differ materially from currently anticipated results, including, challenges inherent in commercializing a newly approved product in clinical applications; sequencing a large number of genomes; potential product performance and quality issues; third-party claims alleging infringement of patents and proprietary rights or seeking to invalidate PacBio's patents or proprietary rights; geopolitical uncertainties; and other risks associated with international operations. Additional factors that could materially affect actual results can be found in PacBio's most recent filings with the Securities and Exchange Commission, including PacBio's most recent reports on Forms 8-K, 10-K, and 10-Q, and include those listed under the caption "Risk Factors." These forward-looking statements are based on current expectations and speak only as of the date hereof; except as required by law, PacBio disclaims any obligation to revise or update these forward-looking statements to reflect events or circumstances in the future, even if new information becomes available.

Contacts

Investors:
Jim Gibson: jamesgibson@pacb.com or ir@pacificbiosciences.com

Media:
pr@pacificbiosciences.com

FAQ

What did PacBio announce about NMPA approval on Nov 4, 2025 for PACB?

PacBio announced the Sequel II CNDx system received NMPA Class III approval in China via partner Berry Genomics, enabling clinical long-read HiFi sequencing.

How will the NMPA approval affect availability of PACB sequencing in China?

Berry Genomics is authorized to deploy an end-to-end long-read clinical workflow in China, initially offering a thalassemia assay for hospitals and diagnostic labs.

What tests can the Sequel II CNDx system run for PACB technology after approval?

The system supports assays for carrier, prenatal, newborn, and rare disease testing, beginning with thalassemia and with plans to expand to other single-gene disorders.

What technical advantages does PACB HiFi sequencing offer under the approval?

HiFi sequencing provides long reads (≥20 kb) with high accuracy, detecting SNVs, indels, CNVs, SVs, repeat expansions and enabling phasing in one run.

Does the approval mean immediate countrywide use of PACB systems in China?

Approval permits Berry to deploy the Sequel II CNDx in clinical settings, but rollout timing and lab adoption depend on local implementation and validation.