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IVD Products

In vitro diagnostics (IVD) refers to tests performed on human samples to support precision medicine—helping to identify and guide suitable targeted therapies, immunotherapies, or other treatments for cancer patients.


We provide a comprehensive portfolio of CE-IVD marked NGS solutions for oncology, including Nucleic Acid Extraction Kits, tumor NGS assay kits, and integrated bioinformatics systems. With deep expertise and a robust product portfolio, we are committed to serving as your trusted partner in accelerating the commercialization of your cancer therapeutics.

HapOnco® CorePanel Common Solid Tumor Genomic Profiling Kit

solid tumor丨136 genes丨tissue sample

HapOnco® CorePanel Common Solid Tumor Genomic Profiling Liquid Kit

solid tumor丨136 genes丨blood sample

HapOnco® StarPanel Solid Tumor Genomic Profiling Kit

solid tumor丨1326 genes丨tissue sample

HapOnco® StarPanel Solid Tumor Genomic Profiling Liquid Kit

solid tumor丨1326 genes丨blood sample

HapOnco® WESPlus Whole Exome Sequencing Genomic Profiling Kit

solid tumor丨WES丨tissue sample

HapOnco® mClean MRD Detection Kit (Lung Cancer)

Lung Cancer丨170 genes丨blood sample

HapOnco® mClean MRD Detection Kit (Digestive Cancers)

Digestive Cancers丨190 genes丨blood sample

HapOnco® PARPrion HRD Score Detection Kit

solid tumor丨HRD score丨tissue sample

HapEnrich® Nucleic Acid Extraction Kit (Tissue)

HapEnrich® Nucleic Acid Extraction Kit (cfDNA)

GeneBrainTM Cancer Genomics Insight System

CE-IVD APPROVED

HapOnco® CorePanel Common Solid Tumor Genomic Profiling Kit

Packing Specification: 24 Tests/Kit

HapOnco® CorePanel Common Solid Tumor Genomic Profiling Kit is designed to detect 136 genes highly associated with tumor development, progression, treatment, and prognosis in formalin-fixed paraffin-embedded (FFPE) samples from solid tumor patients.

HapOnco® CorePanel Common Solid Tumor Genomic Profiling Liquid Kit

Packing Specification: 24 Tests/Kit

HapOnco® CorePanel Common Solid Tumor Genomic Profiling Liquid Kit is designed to detect 136 genes highly associated with tumor development, progression, treatment, and prognosis in plasma tumor cell-free DNA (cfDNA) from solid tumor patients.

HapOnco® StarPanel Solid Tumor Genomic Profiling Kit

Packing Specification: 24 Tests/Kit

HapOnco® StarPanel Solid Tumor Genomic Profiling Kit is used to detect mutations in 1326 genes that are highly related to tumor occurrence, development, and treatment prognosis in solid tumors, using panel capture, NGS sequencing, and bioinformatics analysis of formalin-fixed paraffin-embedded (FFPE) tumor tissue samples.

HapOnco® StarPanel Solid Tumor Genomic Profiling Liquid Kit

Packing Specification: 24 Tests/Kit

HapOnco® StarPanel Solid Tumor Genomic Profiling Liquid Kit is designed to detect 1326 genes, which are highly correlated with tumor development, progression, treatment, and prognosis, by capturing plasma tumor cell-free DNA (cfDNA) from blood sample of solid tumor patients, followed by NGS sequencing and bioinformatics analysis. It can widely detect tumor gene mutations in the genome.

HapOnco® WESPlus Whole Exome Sequencing Genomic Profiling Kit

Packing Specification: 24 Tests/Kit

HapOnco® WESPlus Whole Exome Sequencing Genomic Profiling Kit is based on high-throughput targeted hybrid-capture sequencing technology (Next generation sequencing , NGS). The assay performs high-quality whole-exome sequencing (WES) on genomic DNA extracted from FFPE tumor tissue samples, covering the complete exonic regions of approximately 20,000 human genes with ultra-deep sequencing depth. This test enables comprehensive detection of single-nucleotide variants (SNVs), small insertions/deletions (InDels), and copy number variations (CNVs), and additionally includes detection of clinically relevant gene fusions/rearrangements, tumor mutational burden (TMB) calculation, microsatellite instability (MSI) assessment, and analysis of hereditary cancer-related genes, providing a broad molecular basis for clinical decision-making.

HapOnco® mClean MRD Detection Kit (Lung Cancer)

Packing Specification: 24 Tests/Kit

HapOnco® mClean MRD Detection Kit (Lung Cancer) is based on the Tumor-naive/agnostic immobilized Panel mode for ctDNA-MRD detection. It is suitable for the in vitro detection of Minimal Residual Disease (MRD) in plasma cell-free DNA samples from patients with non-small cell lung cancer.It is designed by a Panel dedicated to 170 non-small cell lung cancer-related genes.There were 11 targeted drug/drug resistance related genes, 30 hotspot regions of key cancer driver genes, 14 immunoefficacy related genes, This kit covers the recommended genes of WHO guidelines, Chinese expert consensus and literature reports, covering 98.2% of the population of lung cancer, and the mutation types include base replacement (SNV), small fragment insertion deletion (InDel), fusion.

HapOnco® mClean MRD Detection Kit (Digestive Cancers)

Packing Specification: 24 Tests/Kit

HapOnco® mClean MRD Detection Kit (Digestive Cancers) is based on the Tumor-naive/agnostic immobilized Panel mode for ctDNA-MRD detection. It is suitable for in vitro detection of Minimal Residual Disease (MRD) in plasma cell-free DNA samples from patients with gastrointestinal tumors such as colorectal cancer, gastric cancer, esophageal cancer and gastrointestinal stromal tumor. It is designed by a Panel dedicated to 190 gastrointestinal tumor-related genes. There were 14 targeted drug/drug resistance related genes, 15 immunoefficacy related genes, MSI detection and 9 inherited tumor related genes. This kit covers the recommended genes of WHO guidelines, Chinese expert consensus and literature reports, covering 96% of the population of digestive tract tumors, and the mutation types include base replacement (SNV), small fragment insertion deletion (Indel), fusion, and gene rearrangement.

HapOnco® PARPrion HRD Score Detection Kit

Packing Specification: 24 Tests/Kit

HapOnco® PARPrion HRD Score Detection Kit is an in vitro diagnostic product based on next-generation sequencing (NGS) technology. It is designed to detect genome-wide single nucleotide polymorphisms (SNPs) in FFPE tissue samples from solid tumors (including ovarian cancer, breast cancer, prostate cancer, pancreatic cancer, etc.) and calculate the homologous recombination deficiency (HRD) score through an algorithmic workflow, by analyzing three genomic scar indicators: loss of heterozygosity (LOH), telomeric allelic imbalance (TAI), and large-scale state transitions (LST).The kit is intended to assist in evaluating the homologous recombination repair deficiency (HRD status) of tumor samples, providing clinical reference for evaluating patients' potential sensitivity to PARP inhibitors and platinum-based chemotherapy.

HapEnrich® Nucleic Acid Extraction Kit (Tissue)

Sample Type: tumor tissue Packing Specification: 48 tests/box, 96 tests/box

The kit is used for the extraction, enrichment and purification of nucleic acids. The processed products are intended for clinical in vitro diagnostic use.

HapEnrich® Nucleic Acid Extraction Kit (cfDNA)

Sample Type: whole blood Packing Specification: 48 tests/box, 96 tests/box

The kit is used for the extraction, enrichment and purification of nucleic acids. The processed products are intended for clinical in vitro diagnostic use.

GeneBrainTM Cancer Genomics Insight System

The system integrates a tumor NGS intelligent analysis and interpretation platform with high-performance computing and storage capabilities. It combines data demultiplexing, data analysis, report interpretation, sample management, data management, and knowledge base management into a unified solution. Equipped with patented bioinformatics software, databases, and interpretation knowledge bases, the system enables intelligent and automated processing from raw sequencing data to final reports. Designed to ensure data security, it can operate independently of public networks, specifically addressing the challenges of in-hospital clinical NGS implementation, including bioinformatics analysis, report interpretation, data management, and network security—making NGS simpler and more accessible.

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