Borcher Biotech's Septin9-Based Colorectal Cancer Early Detection Test Pioneers Inclusion in Shanghai Medicare, Bridging the Last Mile in Cancer Screening Accessibility

Borui Cheng remains committed to its mission of “keeping more people free from cancer and major diseases,” striving to advance early detection, diagnosis, and intervention for serious conditions. Since November 2020, two of Borui Cheng’s pioneering in vitro diagnostic (IVD) products for early cancer screening—the first of their kind in China—have been successively included in the medical insurance reimbursement lists of Fujian Province, Beijing, and Shanghai. This development holds significant importance for cancer prevention and control in China, as well as for managing medical insurance expenditures.

Colorectal cancer (CRC) is one of the major cancers threatening human life and health. Extensive research and clinical practice have demonstrated that CRC screening, along with early diagnosis and treatment, can effectively reduce mortality rates.

Currently, detection methods such as colonoscopy, blood-based Septin9 gene methylation testing, fecal occult blood testing (FOBT), and CT colonography are widely used for the early screening and diagnosis of colorectal cancer. Among these, colonoscopy is an invasive procedure and generally has low patient acceptance in China, making it unsuitable as the primary screening method in clinical practice. FOBT is prone to false-positive or false-negative results due to interference, suffers from poor sample homogeneity, and requires stringent testing conditions, leading to low patient compliance.

PCR-based detection of Septin9 gene methylation in blood is a highly advantageous technical approach.Requiring only 10 mL of peripheral blood, the procedure offers convenient sampling and high patient compliance. Moreover, this technical approach demonstrates high sensitivity in detecting early-stage colorectal cancer—5 to 10 times greater than that of traditional tumor marker tests—significantly improving the detection rate of early-stage cancers. Meanwhile, the PCR technology platform is highly favored in the market due to its cost-effectiveness and relatively superior performance. It is suitable for early detection of single or multiple cancers, as well as for monitoring treatment efficacy and recurrence.

Boercheng has deeply cultivated the field of gene methylation detection, focusing on the “deep-water zone” of early cancer screening—serious medical care—and pioneered the introduction of innovative technologies applying gene methylation to early cancer detection in China. In 2014, SiboDing, the first domestic product for early colorectal cancer detection,^®The “Septin9 Gene Methylation Detection Kit” entered the special review procedure for innovative medical devices and was officially approved as a Class III medical device in 2015, becoming China’s first blood-based gene methylation detection product for colorectal cancer using liquid biopsy.

Siboding^®It offers the advantages of high sensitivity and high specificity, with detection sensitivity and specificity reaching 76.6% and 95.9%, respectively,Received high praise from the NMPA (National Medical Products Administration) as “the first of its kind in China, with significant clinical application value”, providing clinicians with authoritative and rigorous diagnostic and decision-making references, serving as an effective adjunct for early diagnosis of colorectal cancer, significantly improving the early detection rate of colorectal cancer and reducing the cancer burden.

Early cancer detection represents a critical breakthrough in overcoming the challenges of cancer treatment and holds significant importance for the Healthy China Strategy and healthcare cost containment. Many regions have successively incorporated early cancer screening, detection, and diagnostic services into their medical insurance coverage. It has become an inevitable trend for early cancer screening and detection products with established clinical validity to be covered by medical insurance. This time, Spod^®Inclusion in the Shanghai Medical Insurance Scheme meansHealth insurance is making significant strides toward disease prevention, with a focus on early cancer screening.Blood-based gene methylation tests, represented by early detection assays and characterized by their rigorous medical attributes, are poised for widespread inclusion in China’s national medical insurance system.

Although colorectal cancer is highly aggressive, its development largely follows the “adenoma–carcinoma” sequence. The progression from precancerous lesions to invasive cancer typically takes 5 to 10 years, providing a critical window for early diagnosis and clinical intervention. Furthermore, the prognosis of colorectal cancer is closely linked to the stage at initial diagnosis. The 5-year relative survival rate for stage I colorectal cancer is 90%, whereas it drops to only 14% for stage IV disease with distant metastasis. Extensive research and clinical practice have demonstrated that screening, along with early diagnosis and treatment, can effectively reduce mortality from colorectal cancer.

The financial burden of out-of-pocket expenses for early cancer detection is one of the primary reasons for the low coverage and adoption rates of early cancer screening and diagnosis. This results in many cancer patients being diagnosed at an advanced stage, leading to high treatment costs, low cure rates, and a substantial overall economic burden. It is reported thatEarly detection and immediate treatment versus late-stage detection followed by treatment result in a more than tenfold difference in medical costs.. Early detection can effectively prevent cancer from progressing to advanced stages, reduce the high costs of later-stage treatment, lower the overall expenditure on cancer-related healthcare insurance, and hold clear significance in health economics.Inclusion in the national medical insurance scheme is an effective approach to increasing the coverage and accessibility of early cancer screening; conversely, expanding the coverage and accessibility of early cancer screening will effectively support cost containment within the medical insurance system.

This Sibo Ding^®“Inclusion of the Septin9 Gene Methylation Test in Medical Insurance” is a thoughtful initiative by Shanghai to effectively promote the widespread availability and accessibility of early cancer screening through targeted medical insurance reimbursement policies.

Since its inception, Borui Cheng has been deeply engaged in the early diagnosis and intervention of major diseases, including cancer, cardiovascular and cerebrovascular diseases, and geriatric conditions. The company is committed to providing the public with products and services for the early diagnosis and intervention of major diseases that are early-stage, precise, safe, highly compliant, and broadly applicable. After more than a decade of development, Borui Cheng has become a pioneer and leader in China in the full-chain industrialization of early detection, diagnosis, and intervention of cancer. It has established a technological and industrial platform for early cancer detection based on liquid biopsy and gene methylation principles, yielding Siboding^®HesiBowei^®Two Major Achievements.

2014, Sibo Ding^®(Septin9 Gene Methylation Detection Kit) entered the Special Review Procedure for Innovative Medical Devices and was approved as a Class III medical device. This is the first gene methylation detection product approved by the NMPA in China for the early detection of colorectal cancer.

In 2017, Sibowei^®(The RNF180/Septin9 Gene Methylation Detection Kit) was also included in the National Special Review Procedure for Innovative Medical Devices and received approval as a Class III medical device in 2020, becoming the only gene methylation product approved worldwide for early gastric cancer detection and gastric cancer risk monitoring in high-risk populations. It enables convenient and rapid detection of early gastric cancer and has been included in the Beijing Municipal Medical Insurance list, eligible for full reimbursement.

BorCheng’s two products are also at the forefront of the industry in terms of commercialization. Currently, SiBoDing^®Included in the medical insurance coverage of Fujian, Beijing, and Shanghai, SiBowei^®It has also been included in Beijing’s medical insurance coverage. Furthermore, Boercheng has co-established blood-based gene methylation testing platforms with nearly 200 Grade A tertiary hospitals across China, which will also accelerate the in-hospital implementation of its gene methylation testing products.

Furthermore, leveraging the advantages of gene methylation detection technology, Boercheng is continuously expanding its presence in other areas of early cancer screening and diagnosis. Upholding its mission to “keep more people free from cancer and major diseases” and guided by its vision to “lead the early detection, diagnosis, and intervention of major diseases for the benefit of all,” the company is actively broadening the application of these approaches. With a robust product pipeline, including products under development for esophageal cancer, multi-cancer gastrointestinal screening, and NGS-based pan-cancer screening, Boercheng is committed to providing high-quality, authoritative, cost-effective, user-satisfactory, and insurance-reimbursable products and services to the market.