Epur Biological Discovers Universal Cancer-Only Methylation Markers Enabling Precision Oncology Across All Cancers

Cervical cancer is a common malignancy among women in China. According to the latest global cancer statistics for 2020, there were 110,000 new cases of cervical cancer in China that year, with its incidence ranking second among all malignant cancers in women.

Fortunately, the etiology of cervical cancer is well-defined, making it a malignancy that can be detected and prevented at an early stage. The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) have confirmed that persistent infection with high-risk human papillomavirus (HPV) is closely associated with cervical cancer. Furthermore, the progression from common cervical inflammation to invasive carcinoma typically takes 10 to 20 years, providing a favorable window for early detection and intervention.

In November 2020, the World Health Organization (WHO) released the Global Strategy to Accelerate the Elimination of Cervical Cancer, marking the first time the global community has committed to eliminating a specific cancer. Although high-risk human papillomavirus (HPV) infection is the primary risk factor for cervical cancer, not every infected individual will develop the disease. For those infected with high-risk HPV, the situation is akin to the proverbial "other shoe waiting to drop." Regarding early tumor screening, what constitutes "early" detection? If high-grade squamous intraepithelial lesions (HSIL), a precancerous stage of cervical cancer, can be detected and intervened upon through procedures such as conization, the tumor can undoubtedly be nipped in the bud, making the elimination of cervical cancer a tangible possibility. However, reality is often harsh. Thinprep Cytologic Test (TCT) and Human Papillomavirus (HPV) testing are currently the most commonly used screening methods for cervical cancer. While TCT is cost-effective, it is significantly influenced by subjective factors related to sample collection and interpretation, leading to a higher risk of misdiagnosis and missed diagnoses. Therefore, there is an urgent need to improve its sensitivity.HPV testing is the primary method for current cervical cancer screening, with high sensitivity; however, since most HPV infections are transient, HPV testing has poor specificity.

The Issue of Excessive Anxiety and Overtreatment Among HPV-Positive Individuals Cannot Be Overlooked, there is an urgent clinical need for practical and feasible methods,Implement risk-stratified management for HPV-positive patients to accurately identify those with high-grade lesions,only then can the goal of eliminating cervical cancer be achieved.

DNA methylation is closely associated with early tumorigenesis and offers significant advantages in early cancer screening for cancers such as cervical cancer. Shanghai Epigenomics Biotechnology Co., Ltd. (hereinafter referred to as “Epigenomics Biotech”) has deeply cultivated the field of DNA methylation. Guided by its mission to “enable everyone to stay free from cancer,” the company detects methylation at specific loci of DNA fragments in clinical samples. This approach circumvents the drawbacks of traditional examination methods and the limitations of surgical or needle biopsy sampling, thereby enabling not only precise early cancer detection but also real-time monitoring of cancer initiation and progression.

Among them, for cervical cancer screening, Yipu Bio has already based on its proprietaryUniversal Cancer-Only Methylation (UCOM), developed a comprehensive DNA methylation solution for cervical cancer,Enables early screening for cervical cancer and differentiation of the various stages of cervical lesion progression, allowing for precise identification of patients with high-grade lesions.It is of great significance for the prevention and treatment of cervical cancer.

Heze, Shandong is one of the cradles of the Chinese nation. Data shows that in 2019, there were a total of 61,952 deaths in Heze City, with malignant neoplasms ranking as the leading cause of death. It is therefore imperative to promote early cancer screening. On April 17, Yipu Biotech facilitated“[STAMP Purple Ribbon] Eradicating Cervical Cancer: We Are Taking Action”Large-Scale Public Welfare Campaign Launched in Heze, ShandongA large-scale public welfare campaign was launched in Heze, Shandong Province. The initiative aims to provide 10,000 free cervical cancer DNA methylation screening tests for women in the Heze region, aligning with the national “Two-Cancer Screening” program. At the launch event, Zhang Lun, Mayor of Heze City, stated that this public welfare campaign, themed “Eliminating Cervical Cancer: We Are in Action,” would facilitate early detection and treatment of cervical cancer, thereby effectively enhancing the level of health protection for women in the Heze area.

Zhang Lun, Mayor of Heze City (fourth from left); Professor Zhu Tongyu, Vice President of Zhongshan Hospital Affiliated to Fudan University and Deputy Director of Shanghai Shenkang Hospital Development Center (fourth from right); Professor Xing Jinliang, Chairman of the Tumor Marker Professional Committee of the China Anti-Cancer Association (third from left); Professor Wang Yudong, Vice President of International Peace Maternity and Child Health Hospital Affiliated to Shanghai Jiao Tong University (third from right); Hao Pijin, Director of the Management Service Center of Heze Modern Medicine Port (second from left); Zhang Shanjia, Director of Heze Municipal Health Commission (second from right); Professor Yu Wenqiang, Chief Scientist of Epu Bio (first from left); and Wang Min, Chairwoman of Heze Women’s Federation (first from right) jointly launched the public welfare campaign “【STAMP·Purple Ribbon】Eliminating Cervical Cancer, We Are in Action.”

Professor Yu Wenqiang, Chief Scientist at EpuBio, stated, “Our preliminary studies validated the superiority of pan-cancer biomarkers in early cervical cancer screening using over 1,000 clinical samples from multicenter, double-blind trials. We hope that our public welfare campaign, ‘STAMP·Purple Ribbon: Action to Eliminate Cervical Cancer,’ will benefit women widely. In the first phase, we are conducting cervical cancer screening in the Heze region. Through relentless efforts, we aim to precisely identify patients with high-grade lesions, reduce the incidence of cervical cancer, enhance awareness of early cancer screening among women, and decrease local medical insurance expenditures. In the future, we will expand our early cervical cancer screening solutions to more regions.”

Cancer biomarkers refer to a class of substances that reflect the presence and growth of cancer, produced either by cancer cells themselves or abnormally generated or elevated by the host in response to cancer cells during the initiation and progression of the disease. These include proteins, hormones, enzymes, DNA mutations, and DNA methylation.

Detection of cancer biomarkers facilitates early cancer screening, aids in diagnosis, and helps determine prognosis. Currently, the market offers two types of solutions: single biomarker tests and pan-cancer biomarker panels. Single biomarker tests are cost-effective, easier to implement, and carry lower risk; however, due to the complex mechanisms underlying cancer initiation and progression, existing studies have demonstrated that single biomarkers have certain limitations in applications such as early cancer screening and companion diagnostics.Pan-cancer biomarkers refer to the inclusion of various common tumor-associated biomarker tests into a single large panel., theoretically enabling the detection of more cancer-related information,However, high-throughput sequencing is often required to analyze hundreds of gene loci. This approach is not only costly, but its accuracy in real-world settings remains suboptimal due to the cumulative effect of errors at each individual locus, posing challenges for clinical adoption.

Both single biomarkers and pan-cancer biomarkers have limitations. Consequently, researchers have proposed an ambitious and bold hypothesis: Is it possible to identify a class of biomarkers that are specifically present across all cancer types, enabling simple, low-cost, and precise detection of cancers in all human organs?

Yipu Bio has turned this vision into reality.

Professor Yu Wenqiang, Chief Scientist at EpiBiome, is a Principal Investigator of the National “973” Program, a Chang Jiang Scholar Distinguished Professor, and the Principal Investigator (PI) of the Center for Epigenetics at Fudan University’s Institute of Biomedical Sciences. With 10 years of clinical medical experience and over two decades dedicated to epigenetics research, he has conducted in-depth studies at world-leading epigenetics laboratories, including Uppsala University in Sweden, Johns Hopkins University, and Columbia University in the United States. Adopting an epigenetic perspective, he has strived to identify commonalities across cancers, firmly believing that “commonalities and individual characteristics exist in all things, and cancer should be no exception.” After eight years of arduous effort, he successfully discovered a class of biomarkers specifically present in all cancers—pan-cancer biomarkers. This original achievement has been published in the prestigious international academic journal Cancer Research.

"Pan-cancer biomarkers" is a novel concept proposed by YiPu Ren. Professor Yu explained the meaning of pan-cancer biomarkers as follows: "Pan-cancer biomarkers are present in all tumors, remaining unchanged regardless of tumor type or disease stage, and unaffected by differences in human populations across countries. Therefore, pan-cancer biomarkers are not only Chinese biomarkers but also global biomarkers."

Across nearly 10,000 cases encompassing more than 13 different types of real-world clinical samples, the pan-cancer biomarker has been effectively validated by Epu Bio using a double-blind method. Furthermore, data from nearly 7,000 cases covering more than 17 common cancer types in the internationally renowned The Cancer Genome Atlas (TCGA) database have confirmed the actual existence of this pan-cancer biomarker. It is particularly important to emphasize that the pan-cancer biomarker differs fundamentally from what is commonly referred to as a "pan-cancer marker"; simply put,Pan-cancer biomarkers enable “one-to-many” testing, truly achieving comprehensive tumor detection in a single assay!Pan-cancer biomarkers employ a "many-to-many" detection strategy, loosely combining various tumor-associated markers into a large panel encompassing multiple genes and loci. The aim is to detect a broader range of cancers through combinatorial analysis in a single test. While theoretically feasible, this approach represents a compromise in tumor detection. In contrast, universal cancer biomarkers target markers specifically present across all cancer types, typically assessing only 1–2 loci, thereby enabling simple, rapid, and precise undifferentiated detection of multiple cancers.Compared with pan-cancer biomarkers, whole-cancer biomarker assays require fewer detection sites, do not rely on high-throughput sequencing, and can be performed using qPCR. This approach significantly reduces testing costs while maintaining excellent specificity and sensitivity.”

What is certain is that the discovery of pan-cancer biomarkers,Challenging the industry’s prevailing belief that “detecting more cancers requires more loci and incurs higher costs,”It will make outstanding contributions to the global market for molecular diagnostics in cancer, ushering in a new era of cancer diagnosis and treatment.

Based on pan-cancer biomarkers, Yipu Bio has launched three clinically urgent solutions—Cervical Cancer DNA Methylation Screening Program, Urothelial Carcinoma DNA Methylation Solution, and Rapid Molecular Pathology Solution for Pan-Cancer DNA Methylation.

Developed by Yipu BioCervical Cancer DNA Methylation Screening Protocol Can Assist HPV in Cervical Cancer Screening and Risk Stratify HPV-Positive Patients.Data show that this test has a screening specificity of 90.1% and sensitivity of 78% for high-grade squamous intraepithelial lesions (HSIL) of the cervix; a specificity of 100% and sensitivity of 95.7% for cervical cancer; and an overall screening specificity of 90.1% and sensitivity of 80.8% in the high-risk population for cervical cancer. For hrHPV-positive patients,Risk stratification management using this product can increase the specificity for hrHPV from 20% to 71.8%.

Early screening and recurrence monitoring represent two major challenges in the clinical diagnosis and treatment of urothelial carcinoma (including bladder cancer, ureteral cancer, renal pelvic cancer, etc.). Yipu Bio has developedA Comprehensive DNA Methylation-Based Solution for Urothelial Carcinoma: Requiring Only 10 mL of Urine, It Enables Early Screening for High-Risk Populations, Diagnosis for Suspected Cases, Treatment Efficacy Assessment, Recurrence Risk Evaluation, and Long-Term Recurrence Monitoring, Facilitating Convenient At-Home Testing.

Furthermore, to address the severe shortage of pathologists in China and the issues of missed and misdiagnoses caused by variations in pathological expertise across different regions, Epigenomics Biotech has developed a pan-cancer DNA methylation molecular pathology diagnostic platform. This platform provides rapid, automated, and standardized assistance to pathologists for expedited diagnosis.

Pan-Cancer DNA Methylation Molecular Pathological Diagnosis PlatformMolecular diagnosis of benign and malignant masses can be performed using samples derived from target organs; currentlyCapable of detecting nearly 20 cancer types, including lung cancer, liver cancer, and colorectal cancer, and able to process more than 10 sample types, such as tissue, blood, and urine.Covers the entire cancer diagnosis and treatment process, including early cancer screening, auxiliary diagnosis, and efficacy assessment.Validated with over 10,000 clinical samples, the platform demonstrated an overall concordance rate exceeding 90%.

Currently, Epigenomics Biotech is actively collaborating with hospitals and third-party medical laboratories to promote its three core services: the DNA methylation screening solution for cervical cancer, the DNA methylation solution for urothelial carcinoma, and the pan-cancer DNA methylation molecular pathology diagnostic platform.

Yipu Bio: A Promising Future! As a pioneer and practitioner in pan-cancer biomarkers, Yipu Bio is now fully equipped to conquer formidable challenges. With profound medical benevolence and an unwavering commitment, we are determined to serve humanity. Building on our pan-cancer biomarker platform, Yipu Bio will address clinical needs and pain points by delivering more molecular diagnostic solutions for cancer, covering a broader range of cancer types. We aim to spark a revolution in cancer diagnosis and treatment, so that people no longer live in fear of the word “cancer,” and the phrase “Go Away, Mr. Tumor” transitions from a mere joke to a tangible reality.