OriGene Bio's Liver Cancer Early Detection Product Liweiping®, the World's First '6-Gene Methylation + AI Analysis Software' Dual Class III IVD System, Receives NMPA Approval

China’s liver cancer incidence remains persistently high, imposing a substantial disease burden. According to the latest data on the burden of malignant neoplasms in China, released by the National Cancer Center in 2024, China ranked first globally in both new cancer cases and cancer-related deaths in 2022.^[1]. Particularly noteworthy is that the incidence of liver cancer has risen to the fourth highest in China, while its mortality rate has surpassed that of gastric cancer to rank second, making it the leading cause of death among malignant tumors of the digestive system.

Liver cancer has an insidious onset, rapid progression, and high malignancy, with most cases already at an intermediate or advanced stage at the time of diagnosis. Studies have shown that early detection and timely treatment can significantly improve the five-year survival rate for liver cancer patients. However, the five-year survival rate for liver cancer in China is less than 15%, and the early diagnosis rate is only 21.4%, showing a significant gap compared to neighboring countries such as Japan and South Korea.^[2-6], the situation in liver cancer prevention and control remains severe. Efficient early screening and diagnosis for high-risk populations are key to shifting diagnosis and treatment to earlier stages, improving survival rates, and reducing treatment costs.

Current Early Diagnostic Methods for Liver Cancer: Significant Limitations

■ 6-Gene Synergistic Detection | Multi-Pathway Coverage, Enhanced Detection Performance

The development of liver cancer is often accompanied by multi-gene methylation abnormalities, Li Weiping^®Based on cutting-edge global research into liver cancer methylation, this approach precisely captures the “molecular traces” of very early-stage liver cancer by simultaneously analyzing methylation abnormalities in six liver cancer driver genes: TSPYL5, RASSF1A, DAB2IP, OTX1, PTPN18, and HIST1H3G. It provides a high-sensitivity, high-specificity precision early-diagnosis solution for individuals at high risk of liver cancer, enabling earlier intervention and optimal treatment timing for patients.

■ AI-Powered | Reagents + Software, Both Class III Medical Devices, Ensuring Stable and Reliable Testing

Li Weiping^®Innovatively integrating AI-powered analytical models to achieve standardization and digital-intelligent transformation across the entire testing workflow.

This breakthrough means that early screening and diagnosis of liver cancer no longer rely on a single test kit. Instead, intelligent analysis makes testing more efficient and accurate, ushering in an era of “intelligent diagnosis” for the early detection of liver cancer.

A multicenter clinical study led by the First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army, with the participation of six institutions including the Second Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation Army, the Affiliated Tumor Hospital of Guangxi Medical University, Beijing You'an Hospital Affiliated to Capital Medical University, the First Affiliated Hospital of Zhengzhou University, and the Fifth People's Hospital of Ganzhou City, has shown that:

■ Broad Applicability | Non-invasive and Convenient, Covering Full-Cycle Health Management

Li Weiping^®Suitable for the following populations, facilitating early screening and diagnosis of liver cancer:

Meanwhile, Li Weiping^®It is not only applicable for the early diagnosis of liver cancer but also demonstrates excellent potential in recurrence monitoring. Baseline samples are collected from patients prior to treatment, followed by regular postoperative testing. By leveraging the dynamic changes in methylation markers to warn of recurrence risk, this approach captures recurrence trends earlier than conventional imaging examinations, thereby providing a critical basis for therapeutic decision-making.

■ Standard Recognition | Methylation Technology Recommended by Multiple Authoritative Guidelines

In recent years, methylation testing for liver cancer has gained recognition from multiple authoritative guidelines and consensus statements both domestically and internationally, and is being progressively incorporated into clinical screening and diagnostic systems.

● The "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" state: "Specific epigenetic modification features of genes, such as methylation and 5-hmC, can also be used for the early diagnosis of liver cancer."

● The "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Primary Liver Cancer 2024" state: "DNA methylation demonstrates high sensitivity and specificity in liver cancer screening and early diagnosis, enabling the detection of liver cancer prior to abnormal imaging findings, facilitating the diagnosis of early-stage liver cancer, and enhancing the efficacy of liver cancer screening."

● The "Consensus on Secondary Prevention of Primary Liver Cancer (2021 Edition)" emphasizes: "ctDNA methylation has specific advantages in the diagnosis of HCC."

The recommendations in the above guidelines fully affirm the clinical value of methylation testing. Li Weiping^®As the world’s first early liver cancer screening product based on 6-gene methylation analysis combined with an AI model, it will lead technological innovation and standard upgrades in this field.

ORIOMICS has remained committed to the research, development, and clinical translation of early cancer screening technologies. As a global innovator in this field, ORIOMICS has filed more than 50 invention patents and software copyrights, with its service network covering dozens of major Grade A tertiary hospitals across China. On March 21, 2025, the U.S. Food and Drug Administration officially granted ORIOMICS’ Liwei’an^®— “Breakthrough Medical Device” Designation for the Multi-Gene Methylation and Protein Multi-Omics Screening Reagent for Liver Cancer and Its Accompanying Analysis Software. This product is suitable for liver cancer monitoring in various high-risk populations, including individuals with chronic hepatitis, excessive alcohol consumption, non-alcoholic liver disease, cirrhosis, and a family history of liver cancer, demonstrating broad applicability potential in complex risk contexts. Li Weiping^®Listing and Liwei'an^®international recognition, both based on ORIOMICS' core technological accumulation in liquid biopsy, epigenetics, and bioinformatics analysis; the two form a strong synergistic effect: the former focuses on clinical auxiliary diagnosis scenarios, while the latter extends to more upstream large-population risk screening. The "reagent + AI software" dual-certified product Liweiping^®Its market launch marks China’s formal entry into the “era of digital-intelligence precision” for early liver cancer screening! In the future, ORIOMICS will wield methylation-based diagnosis and treatment as a sharp tool to continuously break through technical barriers in early cancer detection, empowering the shift of the “golden window for early diagnosis” to an earlier stage. This will leave latent cancer cells nowhere to hide and enable hundreds of millions of Chinese people to take the initiative in the race against time for their lives.

Precision Methylation Testing: One Step Earlier in Screening, A Lifetime of Health!

Hangzhou Ao Rui Biological Technology Co., Ltd., located in the Qiantang New Area of Hangzhou, is a "National High-Tech Enterprise" dedicated to providing comprehensive solutions for "precision medicine" in oncology and gastrointestinal health. The company’s core technical team comprises experts from renowned medical schools and cancer centers in China and the United States, and it hosts the "Provincial High-Tech Research and Development Center for Non-Invasive Early Screening and Diagnosis of Tumors." Keeping pace with the era of precision oncology treatment and whole-process management, the company continuously expands the research, development, and application of products covering the entire tumor diagnosis workflow through sustained technological innovation and optimization. These applications include early screening, auxiliary diagnosis, medication guidance, efficacy evaluation, treatment monitoring, detection of recurrence and drug resistance, and prognostic monitoring. Leveraging its robust biotechnology and bioinformatics teams, the company employs non-invasive liquid biopsy technology combined with next-generation sequencing (NGS) and its proprietary dual-layer machine learning core algorithms based on big data artificial intelligence analysis. This approach enables genome-wide analysis and comparison of multi-omics tumor characteristics, such as copy number variations and methylation, in early-stage cancer patients, thereby establishing an early screening and diagnostic technical system covering multiple cancer types. Currently, the company’s product portfolio spans the early screening field for various malignant tumors, including liver cancer, colorectal cancer, gastric cancer, pancreatic cancer, and esophageal cancer, providing comprehensive solutions to promote early diagnosis and treatment of cancer.

Mission: To ensure early detection for every cancer patient.

Vision: To become a world-class provider of cancer diagnostic products