Recently, after a strict approval process, the REG1A serum reagent independently developed by Shenzhen Shengbo Life Science Technology Co., Ltd. has been officially obtained the medical device registration certificate issued by the Guangdong Provincial Drug Administration after the Guangdong Provincial Drug Administration innovates the green channel and the State Drug Administration for the record20252400165）。 The advent of this innovative reagent fills the gap of the lack of specific and sensitive serum markers in the current diagnosis and treatment pathway of digestive tract diseases, provides clinicians with more accurate and efficient auxiliary diagnostic tools, and is expected to greatly improve the early diagnosis rate of gastrointestinal diseases and benefit the majority of patients.
Gastrointestinal diseases are a global health problem, and the incidence continues to rise. From common gastric ulcers, gastritis, to serious life-threatening gastrointestinal tumors, these diseases often have insidious symptoms and lack specific manifestations in the early stage, resulting in patients easily missing the best time for treatment. Although traditional diagnostic methods, such as gastroscopy and colonoscopy, are the "gold standard" for diagnosis, they are invasive, cause discomfort to patients, and have certain risks, and some patients have poor compliance. In addition, some existing serological detection indicators have limited sensitivity and specificity, which is difficult to meet the urgent clinical needs for early and accurate diagnosis. Therefore, the development of a convenient, non-invasive, and accurate diagnostic method for gastrointestinal diseases has become a key problem to be solved urgently in the medical field. This innovative product, developed by the R&D team of Shenzhen Shengbo Life Science Technology Co., Ltd., the team of Professor Wan Desen of CUHK Oncology and the team of Professor Wang Xinxin of Zhujiang Hospital of Southern Medical University, will be overexpressed and secreted into the blood when the gastrointestinal mucosa is damaged. A large number of clinical studies have shown that the expression level of REG1A protein in patients with organic lesions of the gastrointestinal tract, especially inflammatory bowel disease, gastrointestinal tumors and other diseases, is closely related to the severity and progression stage of the disease. At the same time, the research of Professor Anderson's team showed that REG1A has high specificity and sensitivity for colorectal cancer when combined with the traditional marker CEA, and the data model (PubMed ID: 38965192, https://pubmed.ncbi.nlm.nih.gov/38965192/) provides a more economical and convenient screening tool for large-scale colorectal cancer screening. The sensitivity and specificity of REG1A combined with the traditional marker CEA for colorectal cancer can reach 81.4%, the specificity can reach 92.8%, and the positive predictive value PPV=95.9% can effectively screen out the high-risk groups who really need to undergo digestive endoscopy. It greatly improves the early detection rate of the disease and effectively reduces missed diagnosis and misdiagnosis. The whole process is non-invasive and painless, and patients do not need to bear the pain and psychological pressure brought by traditional examinations, which greatly improves the acceptance and compliance of patients and helps to carry out large-scale screening. The expression of REG1A in serum was detected by enzyme-linked immunoassay. The testing process is simple, the operation time is short, and an accurate test report can be issued within 2 hours. It is not only suitable for early screening of gastrointestinal diseases, but also can be used for the monitoring of disease treatment effects and prognosis evaluation, providing comprehensive and dynamic information for clinicians to formulate personalized treatment plans. Looking forward to the future, we will build a healthy line of defense The launch of REG1A serum reagent is an important milestone in the field of gastrointestinal disease diagnosis. In the future, we will continue to increase R&D investment, continuously optimize product performance, expand application fields, and strive to bring more innovative and high-quality medical solutions to patients." At the same time, we also look forward to working with medical institutions, scientific research institutions and pharmaceutical companies to jointly promote the progress of medical science and technology and contribute more to the cause of human health.
The dilemma of diagnosing gastrointestinal diseases needs to be broken through urgently
REG1A serum reagent: a new tool for accurate diagnosis
The REG1A serum reagent offers a number of significant advantages
01 High sensitivity and specificity
02 Non-invasive, convenient, and highly compliant
03 Fast and efficient, reliable results
04 Extensive clinical application value