Borcon's Esophageal Cancer Early Detection Solution — First-in-Class, Nation's First NMPA-Approved Methylation Test

On August 7, 2024, the official website of the National Medical Products Administration (NMPA) announced that Boercheng (Beijing) Technology Co., Ltd. had independently developedSiBos® MT-1A, Epo, and Septin9 Gene Methylation Detection Kit (PCR Fluorescent Probe Method) Approved for Market Launch (National Medical Device Registration No. 20243401386)。

This product is in the clinical trial phase and has been jointly validated by six clinical trial centers: Cancer Hospital of the Chinese Academy of Medical Sciences, Xijing Hospital of Air Force Medical University of the Chinese People's Liberation Army, Tangdu Hospital of Air Force Medical University of the Chinese People's Liberation Army, Henan Cancer Hospital, The Second Affiliated Hospital of Xi'an Jiaotong University, and Cancer Hospital affiliated to Shantou University Medical College.The product has a detection sensitivity of 85.5% and a specificity of 93.6%., applicable to patients who have been advised by a clinician to undergo esophagoscopy but refuse the procedure due to personal reasons.

On Friday, November 8, at 19:30, VCBeat New Product Review was honored to inviteDr. Han Xiaoliang, Co-founder/Chief Scientist of Boercheng; Dr. Gan Weiqiong, Marketing Director of BoerchengTwo guests present BorCheng’s product offerings.

Dr. Si^®By capturing MT-1A, Epo, and Septin9 gene fragments released into the bloodstream through tumor cell apoptosis, necrosis, and active secretion, and by detecting changes in their methylation levels, this method assesses the likelihood of esophageal cancer and precancerous esophageal lesions in the subject.

Innovative Biomarkers:First discovery of three methylation biomarkers specific to the Chinese population for esophageal cancer detection; achieved combined detection of the three biomarkers using multiplex qPCR technology, a first in China, significantly improving the sensitivity and specificity of clinical esophageal cancer detection.

Clinical Diagnostic Innovation:This product employs a ctDNA methylation detection technology based on liquid biopsy. By measuring the methylation levels of specific gene loci in tumor-derived DNA from peripheral blood, it achieves highly efficient and precise detection of esophageal cancer, filling a gap both domestically and internationally in the field of early diagnosis of esophageal cancer via gene methylation.

Innovation in Testing Technology:This productDuring product development, technological innovations such as patent-protected probe and blocker design were achieved, enabling high-performance testing with just a single 5 mL blood sample.

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Han Xiaoliang

Boercheng | Co-founder, Chief Scientist

Peking Union Medical College, M.D.

Postdoctoral Fellow, University of California, San Francisco School of Medicine

Chief Scientist, BioChain Institute, USA

Head of the First Gene Methylation Product (Colorectal Cancer) Registered with the National Medical Products Administration

Overall Project Lead for Two National-Level Innovative Medical Device Products (Colorectal Cancer and Gastric Cancer)

Authored the Chinese Anti-Cancer Association’s "Guidelines for Integrated Diagnosis and Treatment of Cancer in China: Liquid Biopsy," edited by Academician Fan Daiming

Authored the First "Expert Consensus on Detection and Clinical Application of Tumor DNA Methylation Biomarkers (2024 Edition)"

Honored with the “Leading Figure” Golden Screen Award in the Early Cancer Screening Industry

Awarded the Title of "Yiqilin Outstanding Talent" in Beijing

Visiting Professor, Business School of the Chinese Academy of Management Science; Member of the Great Power Pharmaceutical Think Tank

Gan Weiqiong

Boercheng | Marketing Director

Ph.D. in Biochemistry and Molecular Biology, Institute of Biophysics, Chinese Academy of Sciences

Served as Senior Product Manager, Planning Manager, and Head of Marketing Department at three publicly listed companies.

Extensive experience in upstream raw materials and downstream IVD product marketing.

Participated in three projects funded by the National Natural Science Foundation of China.

Holds more than ten patents authorized by the China National Intellectual Property Administration

Founded in 2006, Borui Cheng has deeply cultivated the field of early detection, early diagnosis, and early intervention (hereinafter referred to as “Three Earlies”) for major diseases such as cancer, cardiovascular and cerebrovascular diseases, diabetes, and cognitive 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 become an industry leader.

The Company’s blood-based gene methylation detection products for esophageal cancer, gastric cancer, and colorectal cancer are all the first of their kind to receive approval in China. Among these, the gastric cancer and colorectal cancer detection products have been adopted by hundreds of Grade IIIA hospitals and included in medical insurance schemes in multiple regions. The Company maintains a robust product pipeline, with ongoing R&D projects including the POCM series, early diagnosis products for liver cancer and lung cancer, digital PCR products, NGS-based multi-cancer screening programs, and early diagnosis and treatment initiatives for cardiovascular and cerebrovascular diseases such as stroke. Upholding its mission to “keep more people free from major diseases,” Boercheng will continue to expand broader applications in the field of early detection, early diagnosis, and early treatment of major diseases.

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