Products and Services

Burning Rock offers a diversified portfolio of internally developed NGS-based assays and solutions for both tissue and liquid biopsy (blood samples). These products are utilized both in the company's central accredited laboratories and through In Vitro Diagnostic (IVD) kits for hospital-based testing.

1. Therapy Selection and Comprehensive Genomic Profiling (CGP)

This segment focuses on providing detailed genomic profiles for late-stage cancer patients to guide treatment decisions, including targeted therapy and immunotherapy.

• OncoScreen? Plus (Tissue Kit): A flagship Comprehensive Genomic Profiling (CGP) assay for solid tumors. It is a large panel (e.g., 520-gene panel) that covers a wide range of clinically relevant genomic alterations (SNVs, InDels, CNVs, fusions) and complex biomarkers like Tumor Mutation Burden (TMB) and Microsatellite Instability (MSI). It is frequently used in clinical trials and for selecting pan-solid tumor therapy options.
• OncoCompass? Plus (Liquid Biopsy Kit): A corresponding liquid biopsy solution that utilizes circulating tumor DNA (ctDNA) from a blood draw to analyze cancer mutations. This non-invasive approach is crucial for patients with insufficient or inaccessible tissue samples. The technology behind this, such as HS-UMI (High-Sensitivity with Unique Molecular Identifiers), is designed for ultra-low frequency mutation detection in cell-free DNA.
• NMPA-Approved Companion Diagnostic (CDx) Kits: Burning Rock has secured multiple regulatory approvals from China's National Medical Products Administration (NMPA) for its NGS-based kits, such as LungCure? CDx. These kits are specifically approved to detect gene mutations (e.g., EGFR, ALK, ROS1) that determine eligibility for specific targeted drugs in non-small cell lung cancer (NSCLC).
• MyChoice? HRD Plus: An in-licensed test (from Myriad Genetics) to assess Homologous Recombination Deficiency (HRD) status, which is a critical biomarker for predicting the response to PARP inhibitors in cancers like ovarian and breast cancer.
• OncoScreen? HEME: A comprehensive multi-omics panel (e.g., 569 DNA genes and 322 RNA genes) designed for the diagnosis and management of Hematological Malignancies (blood cancers).

2. Minimal Residual Disease (MRD) Monitoring

This area utilizes highly sensitive liquid biopsy assays to monitor cancer recurrence or residual disease after curative-intent treatment.

• CanCatch? (Tumor-Informed and Tumor-Naive MRD Solutions): A product that employs an advanced personalized approach. It first profiles the patient's primary tumor (whole-exome sequencing) to create a custom mutation panel, then uses ultra-deep sequencing of blood samples to detect those specific tumor markers with extremely high sensitivity (as low as 0.004%). This is crucial for real-time relapse surveillance.

3. Early Cancer Detection

Burning Rock is a leader in developing non-invasive tests for the early detection of cancer, aiming to shift diagnosis to a much earlier, more treatable stage.

• OverC? Multi-Cancer Detection Blood Test Kit: A novel, non-invasive test that can detect multiple cancer types from a single tube of blood. The underlying technology, ELSA-seq? (Enrichment- and Ligation-based Sequencing Assay), utilizes high-resolution methylation profiling and machine learning to capture highly diluted cancer signals in circulation. It has received Breakthrough Device Designation (BDD) from both the US FDA and China NMPA for its potential to detect multiple cancers, including lung, esophageal, colorectal, liver, ovarian, and pancreatic cancer.

Specialized Services and Technology Platforms

Beyond diagnostics products, Burning Rock provides extensive support services to clinical research and pharmaceutical partners globally.

Pharma and Biopharma Services

• Companion Diagnostics (CDx) Development: A primary service area involving collaboration with pharmaceutical companies to develop and commercialize NGS-based CDx tests, which are essential for drug approval and patient selection for targeted therapies.
• Clinical Trial Solutions: Providing genomic data solutions, precision patient recruitment services, and central lab testing to facilitate multi-regional clinical trials (MRCTs). The company has collaborations with major global biopharma firms like AstraZeneca, Bayer, and Johnson & Johnson.
• Biomarker Research and Consulting: Offering expertise and services for biomarker discovery and validation studies.

In-Hospital and Sequencing Services

• In-Hospital Business: Providing hospitals with the necessary IVD kits (NMPA-approved) and automated NGS solutions to perform molecular testing in-house. The Magnis BR platform, co-developed with Agilent Technologies, is a fully automated NGS library preparation system designed to streamline the in-hospital workflow, enabling faster report generation with minimal space and staff requirements.
• Sequencing and Multi-omics Services: Offering custom next-generation sequencing services leveraging multi-omics technology to meet diverse research goals for external clients.
• OncoMaster? Tumor Genomics Data Master: A proprietary, fully automated bioinformatics solution for in-house NGS data analysis, interpretation, and report generation, simplifying the complex data processing for hospital partners.

Burning Rock's operations are underpinned by internationally recognized quality management systems, including CLIA, CAP, ISO 15189, and ISO 13485 accreditation, ensuring high-quality, reliable diagnostic results for both clinical use and global research projects.