About BioChain
A leader in early detection, diagnosis, and intervention of chronic diseases
Founded in 2006, BioChain (Beijing) Science & Technology, Inc., or BioChain for short, has since become an industry leader in the early detection, diagnosis, and intervention (hereinafter referred to as the “Triple E”) of chronic diseases. The Company diligently works in the prevention of cancer, cardiovascular and cerebrovascular diseases, diabetes, cognitive disorders, and other chronic diseases. BioChain is committed to providing targeted and safe Triple E products and services with higher medication adherence and broader applicability in the early phase of diseases.
BioChain’s blood-based DNA methylation assay kits for both colorectal cancer (CRC) and gastric cancer are the first self-developed DNA methylation diagnostic products approved by the National Medical Products Administration (NMPA) in China. In addition, they have been applied in hundreds of top-tier hospitals and incorporated into the medical insurance system in many parts of the country. The Company has an impressive pipeline of proprietary products, including the point-of-care monitoring (POCM) series, early diagnostic tools for esophageal, liver, and lung cancers, respectively. It also has a multi-cancer NGS screening platform. Furthermore, BioChain is committed to developing initiatives to diagnose and treat stroke and other cardiovascular and cerebrovascular diseases at an early stage. With the goal of “Safeguarding Your Well-being from Chronic Diseases,” BioChain will continue to refine and expand its “Triple E” applications.
Technological Innovations
The leading innovator in the “Triple E*” approach to chronic diseases
The World’s First
The world’s first blood-based DNA methylation assay kit for the early diagnosis of CRC to be approved by the authoritative FDA (U.S.), NMPA (China), and CE marking (Europe), filling the gap at home and abroad.
The World’s Only
The world’s only DNA methylation assay kit for the early diagnosis of gastric cancer, approved by the NMPA in China.
China’s First
The first NMPA-approved DNA methylation assay kit for the early diagnosis of colorectal cancer in China.
China’s First
The first DNA methylation assay kits for early diagnosis of CRC and gastric cancer in China which have been incorporated into the medical insurance system.
China’s Only
The only company in China to receive two NMPA approvals for innovative medical devices in the field of early cancer diagnosis based on DNA methylation.
Successively selected
Consistently chosen for the China National Key R&D Program during the 13th and 14th Five-Year Plan periods.
World’s Largest
Partnered with Beijing Tiantan Hospital to establish the first Epigenetics Research Joint Laboratory in China. It also participated in the world’s largest cohort study of cerebrovascular accidents (or strokes) in epigenetic studies, involving more than 10,000 participants.
Product System
Comprehensive solutions for the “Triple E*” approach to chronic diseases.
Cancer
Other Chronic Diseases
Infectious Diseases
Others
Authoritative Certifications
Dedicated to developing excellent products and services for the “Triple E*” approach to chronic diseases
At BioChain, we always prioritize the needs of the customer. We have established a comprehensive system for product registration, production management, and quality control that is highly efficient, pragmatic, and fully regulatory-compliant. Every aspect of our operations, from R&D to registration, procurement, production, sales, logistics, and clinical testing services, adheres strictly to quality regulations and standard operating procedures. This approach provides a solid foundation for the development of exceptional products and services that meet the highest standards of excellence.
Product Registration Certificate
NMPA (the National Medical Products Administration, China) Approval
• Dozens of proprietary products have obtained NMPA approval
• Both DNA methylation test kits for the early diagnosis of colorectal cancer (思博定®) and gastric cancer (思博衛(wèi)®) were the first self-developed diagnostic products approved by the NMPA for innovative Class III medical devices
CE Approval
• By 2023, BioChain has received CE marking for a total of 49 proprietary products, including the early cancer detection and diagnostic series, the Point-of-Care Monitoring (POCM) series, and the Novel Coronavirus antibody detection series
Quality Control Certifications
ISO (International Organization for Standardization) Certification
• Acquired ISO13485 certification, the international standard for quality assurance of medical devices
NCCL (National Center for Clinical Laboratories, China) Certification
• From 2015 to 2022, BioChain’s wholly-owned Medical Laboratory acquired the NCCL external quality assessment (EQA) certificate with full scores for 8 consecutive years
