Kangjianyou: China's First Fecal Nucleic Acid Test Kit for Helicobacter pylori Receives Class III Medical Device Registration Certificate

Helicobacter pylori is classified by the World Health Organization as a Group I carcinogen and is one of the primary causes of gastritis, gastric ulcers, and even gastric cancer. Therefore, screening for Helicobacter pylori is of significant importance in reducing the incidence of gastric diseases. Recently, the Helicobacter pylori nucleic acid detection kit, independently developed and manufactured by Kangwei Century, obtained the Medical Device Registration Certificate issued by the National Medical Products Administration. This marks China’s first Class III registration certificate for nucleic acid detection of Helicobacter pylori based on stool samples, filling an industry gap and making testing more accurate and convenient.

The prevalence of Helicobacter pylori infection in the Chinese population is as high as 40%–60%. Due to traditional Chinese dietary habits, H. pylori is easily transmitted among family members; therefore, if one individual is infected, all household members should undergo testing. According to the "Sixth National Consensus Report on the Management of Helicobacter pylori Infection," confirmed H. pylori infections require complete eradication. This implies that 1.4 billion people in China need screening, and 800 million require eradication therapy. As public awareness of health management continues to rise, with the launch of new technologies and products such as fecal nucleic acid test kits for H. pylori, the penetration rate of H. pylori screening is expected to increase steadily, driving continuous growth in the market size for H. pylori screening.

Kangjianyou™ employs PCR fluorescent probe technology to detect Helicobacter pylori nucleic acids in human stool samples, targeting specific gene sequences of Helicobacter pylori.High Sensitivity，High specificityThe test results are not affected by antibiotics, proton pump inhibitors, bismuth agents, and other antimicrobial drugs. The assay can be performed in a standard PCR laboratory, and the extracted nucleic acids can also be used for detecting multiple antibiotic resistance genes. The “Expert Consensus on the Prevention and Management of Helicobacter pylori Infection in Chinese Households (2021)” states that molecular biology techniques can be used to detect H. pylori infection and drug resistance in stool samples, providing important guidance for eradication therapy.

Kangjianyou™ overcomes the limitations of existing diagnostic technologies for Helicobacter pylori detection, such as result interference by antibiotics and radiation hazards. It is suitable for special populations, including pregnant women, children, and the elderly, providing a novel clinical diagnostic technology for H. pylori and offering more precise auxiliary diagnostic evidence to guide eradication therapy regimens.

To provide everyone with a more comprehensive understanding,Tuesday, February 21, 2023, 19:30-20:30, Kangwei Century’s new product, Kangjianyou™, will be launched at the VCBeat Select New Product Showcase. For this event, we have also invitedDirector, Department of Gastroenterology, Nanjing First Hospital; Member, Helicobacter pylori Study Group, Chinese Medical AssociationZhang ZhenyuLaunch our product and share its R&D journey; additionally,Jiao Zhijun, Chief Scientist of Kangwei Century, will introduce the main situation of Kangwei Century in the live broadcast;Liu Zhan, General Manager of Sales at Kangwei CenturyWill also provide an interpretation of business policies during the live broadcast.

Friends participating in this live broadcast will not only gain insights into the product features and sales strategies of “Kangjianyou™,” but also have the opportunity to receive offerings provided by Kangwei Century.Free Trial Slots for Helicobacter pylori Identification and Drug Resistance Testing Services。Scan the QR code in the poster below to register for the live stream:

Member of the Helicobacter pylori Group, Chinese Medical Association; Vice Chairman of the Nanjing Society of Gastroenterology; Standing Committee Member of the Jiangsu Provincial Society of Digestive Endoscopy; Executive Director of the China Office for the Prevention and Control of Helicobacter pylori Infection and Gastric Cancer. Participated in research projects funded by the National Natural Science Foundation of China, the Jiangsu Provincial Administration of Traditional Chinese Medicine, and the Nanjing Municipal Health Bureau, and completed a survey on Helicobacter pylori infection and antibiotic resistance in the Nanjing region. Contributed to research on the relationship between cellular immune responses to Helicobacter pylori infection and gastric cancer, which received the Second Prize for Introduction of New Technologies in Jiangsu Province. The study on the damaging effects and mechanisms of clopidogrel on the gastrointestinal tract was awarded the Third Prize of the Jiangsu Medical Science and Technology Award. Current research focuses on Helicobacter pylori and gut microbiota, with routine implementation of H. pylori culture and drug susceptibility testing in the province to achieve personalized precision treatment for H. pylori infection. Published over 100 papers as the first author.

Recipient of the Taizhou City “113 Special Program for Pharmaceutical Talent” for High-Level Innovative Talents. Awarded a Ph.D. in Immunology from Shanghai Jiao Tong University School of Medicine in 2006; appointed as Professor and Doctoral Supervisor in 2013. Possesses extensive experience in teaching medical laboratory science and managing hospital clinical laboratories. Has received three grants from the National Natural Science Foundation of China (General Program), published over 100 research papers, including 30 indexed by SCI. Served as a Senior Visiting Scholar at the Walter and Eliza Hall Institute (WEHI) of Medical Research in Australia. As the principal investigator, was awarded the Third Prize of Jiangsu Provincial Science and Technology Progress Award, the Third Prize of Jiangsu Provincial Medical Science and Technology Award, and both the First and Second Prizes of the New Technology Introduction Award from the Jiangsu Provincial Health Department.

With 24 years of experience working for world-class medical product manufacturers and a biotechnology background in the genomics industry. Previously held positions at renowned domestic and international medical device companies such as Philips, New Horizon Health, and EUROIMMUN. Consistently responsible for both direct sales of genetic testing IVD products and LDT services, as well as the development of diversified distribution channels.

Jiangsu Cowin Biotech Co., Ltd. (Stock Code: 688426) is a national high-tech enterprise rooted in the life sciences sector, possessing independent intellectual property rights. Leveraging its independently developed key technologies in molecular detection, the company has progressively established a business layout covering major value chain segments of the industry, including core enzyme raw materials, nucleic acid sample preservation, nucleic acid extraction and purification, molecular detection kits, and testing services. Building on its long-accumulated core technologies in raw material enzymes, preservation, extraction, and lyophilization, Cowin Biotech has gradually entered the field of molecular diagnostic reagents in recent years, focusing on two application areas: nucleic acid screening for digestive tract diseases and rapid nucleic acid testing for respiratory infectious diseases. In the future, through continuous technological innovation, Cowin Biotech aims to become an industry leader in the biotechnology sector, realizing its mission of “Empowering Health for Every Life.”

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