Borcheng Tops National Center for Clinical Laboratory's DNA Methylation Proficiency Testing, Poised to Capture the Booming Early Cancer Screening Market

Recently, the National Center for Clinical Laboratories (NCCL) of the National Health Commission announced the preliminary results of the national external quality assessment for Septin9 gene methylation testing. The evaluation involved multiple manufacturers, with half of the participating laboratories selecting Boercheng’s product, SiBoDing.®As a diagnostic reagent, the concordance rate of laboratory test results using this product is 100%.

This assessment marks the first pilot external quality assessment (EQA) program for DNA methylation testing conducted by the National Center for Clinical Laboratories (NCCL). It is expected to significantly promote the standardized development of the gene methylation testing industry and enhance its market penetration. This article provides a detailed interpretation of the relevant aspects of this pilot program.

A total of 10 simulated human plasma samples were distributed as quality assessment samples in this pilot study, including nine positive samples and one negative sample, with varying methylation levels. A total of 60 laboratories participated and submitted valid quality assessment results.Among them, the vast majority selected real-time fluorescent PCR detection (59/60).

Table 1: Expected Results of Septin9 Gene Methylation for Each Sample

Source: National Center for Clinical Laboratories, National Health Commission, “Preliminary Study Report on the External Quality Assessment of Nationwide Septin9 Gene Methylation Testing”

With a passing score defined as ≥90, the overall pass rate for this laboratory assessment was 96.67%. All laboratories correctly identified the methylation-negative samples, yielding a negative concordance rate of 100%. Fifty-six laboratories (93.33%) detected all positive samples, while the remaining four laboratories reported 15 false-negative results. False negatives occurred in 1–3 instances across all positive samples, with an overall false-negative rate of 2.78%. The highest number of false negatives (3/60) was observed for Positive Sample No. 06, which had the lowest methylation level (3.7%). These findings indicate thatAccuracy in Detecting Positive Samples (Especially Those with Low Methylation Levels)—The Positive Concordance Rate Is Key to Laboratory Performance and a Core Indicator for Evaluating the Quality of Gene Methylation Detection Products.

Table 2: Overall Testing Results for Each Proficiency Testing Sample

Source: National Center for Clinical Laboratories, National Health Commission of the People's Republic of China, "Preliminary Report on the External Quality Assessment of Nationwide Septin9 Gene Methylation Testing"

This preliminary study evaluated gene methylation detection reagents from 12 manufacturers. Among them, products from eight manufacturers, including Boercheng, Tujing, and Weizhen, demonstrated superior performance, achieving 100% positive agreement rate and 100% negative agreement rate, thereby making significant contributions to the majority of laboratories attaining perfect scores.

Among the numerous reagent brands involved in this test, Spodine under BorCheng®The Septin9 gene methylation detection kit is favored by most laboratories, with a usage rate of up to 50%.Siboding®In this test, a cumulative total of 300 detections were performed, with all positive and negative samples accurately identified. This fully demonstrates BoerCheng’s industry-leading assay process adaptability and its consistently superior product performance.

Table 3. Test Results of Each Reagent

a. Seven commercially available Septin9 gene methylation detection kits (real-time fluorescence PCR method); b. Four laboratory-developed Septin9 gene methylation detection kits (real-time fluorescence PCR method); c. One Septin9 gene methylation detection assay (targeted bisulfite sequencing method)

Source: National Center for Clinical Laboratories, National Health Commission of China, “Preliminary Report on the External Quality Assessment of Nationwide Septin9 Gene Methylation Testing”

Borcheng’s outstanding performance in this assessment was no accident, but the inevitable result of its long-term commitment to innovative research and development.

In 2006, the core founding team of a company that had been operating in the United States for many years returned to China to establish Borui Cheng (BRC), dedicated to industrializing applications for the early detection and diagnosis of major diseases such as cancer. Under the leadership of Dr. Han Xiaoliang, a graduate of Peking Union Medical College, and other key technical personnel, the BRC team has devoted itself to researching the clinical application of gene methylation technology. The team participated in multiple national key R&D programs, with several projects selected for inclusion in the National “13th Five-Year Plan” Key R&D Special Projects. Throughout this process, the team has accumulated extensive experience in core technological areas, including the development and validation of original biomarkers, blood-based gene methylation testing, and multi-cancer joint detection, and has filed nearly one hundred invention patent applications.

Long-term accumulation has yielded gratifying results: in 2015, Boercheng’s early detection product for colorectal cancer, Siboding®Septin9 Gene Methylation Detection Kit Approved (NMPA Registration No. 20153401481); Sibowei, an Early Gastric Cancer Screening Product, Launched in 2020®RNF180/Septin9 Gene Methylation Detection Kit Approved (NMPA Registration No. 20203400447). Both products are the first of their kind in China and globally, also contributing toBoercheng has become the only company in China’s field of gene methylation-based early cancer diagnosis to obtain two registration certificates under the Special Approval Program for Innovative Medical Devices.

Siboding®Hesibowei®With superior performance metrics, it achieves a 5- to 10-fold higher detection rate for early-stage (Stage 0–II) colorectal and gastric cancers compared to traditional tumor markers. Its broader clinical adoption helps shift cancer prevention and control efforts upstream, enabling more individuals to understand their health status earlier and screen for gastrointestinal cancer risks at an earlier stage.

Comparison of Detection Rates of Various Markers Across Cancer Stages

BorCheng has always adhered to its original mission of “keeping more people free from serious diseases,” forging ahead with determination and deepening its expertise in the early detection and diagnosis of serious diseases.Its technological innovation strength and industrialization capabilities have been repeatedly recognized and affirmed by authoritative institutions such as the National Medical Products Administration (NMPA) and the National Health Commission.

In this national pre-study on external quality assessment for Septin9 gene methylation testing, 50% of laboratories chose Borcheng’s products, highlighting the company’s leading advantage in the field of early colorectal cancer detection. Furthermore,The company has also achieved frequent successes in areas such as medical insurance reimbursement approvals, including its colorectal cancer early detection product, Siboding.^®The methylation testing product series, including [the aforementioned products], has been included in the medical insurance schemes of multiple regions such as Fujian Province, Beijing, and Shanghai. It has been adopted by over 200 Grade A tertiary hospitals and several renowned health checkup institutions, with a cumulative testing volume exceeding one million samples.

Meanwhile, multiple products under Borcheng have obtained EU CE certification. The product portfolio covers cancer early screening and detection series, Point-of-Care Management (POCM) series, and COVID-19 antigen testing series. These product lines meet international standards in terms of technology, quality, and safety, allowing them to be marketed and sold in the 27 EU member states and other countries that recognize EU CE certification. This serves as a strong support and guarantee for Borcheng’s expansion into overseas markets.

As a pioneer in China in the field of “early detection, early diagnosis, and early intervention” for major diseases, Boercheng has expanded from gastrointestinal cancers to other high-incidence malignancies such as liver and lung cancer, and has taken the lead in deploying comprehensive “three-early” solutions for other major conditions, including stroke and cardiovascular and cerebrovascular diseases. Its product pipeline encompasses four categories: immunodiagnostics, gene methylation assays, nucleic acid-based tests, and medical devices.

BorCheng's Core Product Pipeline

The DNA methylation testing sector is entering a phase of rapid volume expansion, with the market for early screening and detection of colorectal cancer poised to evolve into a multi-billion-dollar industry. The results of this preliminary research reflect a high degree of market concentration in DNA methylation testing reagents. Companies with strong R&D capabilities, superior product performance, and leading commercialization progress, such as Boercheng, are well-positioned to fully capitalize on industry dividends and create blockbuster products.

According to the U.S. National Cancer Institute (NCI) and the Chinese Guidelines for Colorectal Cancer Screening, Early Diagnosis, and Early Treatment (2020, Beijing), it is recommended that individuals at average risk undergo colorectal cancer risk assessment starting at age 40, and that individuals aged 50 and above undergo multi-target DNA testing every 1–3 years. According to data provided by Frost & Sullivan, the number of people in China advised to undergo regular colorectal cancer examinations was 646 million in 2020 and is projected to reach 704 million in 2025; the market size for colorectal cancer screening in China was approximately RMB 3.3 billion in 2020 and is expected to exceed RMB 8 billion in 2025.

DNA methylation testing has become a mainstream method for early cancer screening and detection, and may in the future become one of the routine essential items in hospitals and laboratories.ThisThis preliminary study demonstrates the National Clinical Research Center’s recognition of the value of DNA methylation testing in the clinical diagnosis and treatment of cancer. It is expected to further increase industry attention and discussion on DNA methylation, thereby accelerating the issuance of relevant guidelines and consensus statements, as well as the development of technological pathways for DNA methylation testing.

Since the outbreak of the COVID-19 pandemic, the coverage of PCR testing platforms across medical institutions at all levels has increased significantly. This assessment demonstrates that laboratories have achieved a high level of accuracy in methylation detection, and the operational procedures for methylation testing are highly standardized.At present, the construction of DNA methylation detection platforms and the standardization of detection technologies in China are becoming increasingly refined, laying a solid foundation for the application and promotion of DNA methylation testing.

Furthermore, driven by proactive policies such as “Healthy China 2030,” gene methylation testing services, exemplified by early cancer screening and detection, have been included in the medical insurance reimbursement lists in many regions. For market pioneers like Bo’ercheng, expanded insurance coverage is expected to further accelerate the market adoption of gene methylation products, thereby benefiting a larger patient population.

Founded in 2006, Boercheng has deeply cultivated the field of early detection, diagnosis, and intervention (hereinafter referred to as “Three Earlies”) for major diseases such as cancer and cardiovascular and cerebrovascular disorders. Committed to providing the public with early, precise, safe, highly compliant, and broadly applicable products and services for the “Three Earlies” of major diseases, the company has emerged as an industry leader.

The Company’s blood-based gene methylation detection products for colorectal cancer and gastric cancer are both the first of their kind to receive approval in China. They have been adopted by hundreds of Grade 3A hospitals and included in medical insurance schemes across multiple regions. The Company maintains a robust product pipeline, with ongoing R&D efforts covering the POCM series, early diagnostic products for esophageal cancer, NGS-based multi-cancer screening projects, and early diagnosis and treatment initiatives for cardiovascular and cerebrovascular diseases such as stroke. Upholding its mission to “keep more people free from cancer and other major diseases,” Boercheng will continue to expand broader applications in the “three earlies” (early prevention, early detection, and early treatment) field for major diseases.