Recently, the human regenerative pancreatic islet-derived protein 1α detection kit ® was officially approved for the Medical Device Licence (medical device license) issued by Health Canada. This is not only a "pass" to the Canadian market, but also a comprehensive international recognition of Shengbo's R&D, production and quality system, marking that the product fully meets the requirements of Canada, a globally recognized high-standard market, in terms of safety, effectiveness and stability.
Won the "pass" of the Canadian market, and the quality system has been recognized internationally
Canada is one of the most regulated markets for medical devices globally. This approval means that Shengbo has not only successfully passed the strict review of the safety and efficacy of REG1A detection kits by Health Canada, but also fully met the top international standards of MDSAP.
The MDSAP system is jointly led by the regulatory agencies of Canada, the United States, Australia, Japan and Brazil, and its audit covers the entire life cycle of medical devices "design and development, manufacturing, quality control, and after-sales monitoring", and is known for its "high standards, whole chain, and cross-border mutual recognition". This approval marks that Shengbo's R&D strength and quality management level have been in line with the first echelon of the world, which is not only a "pass" for the Canadian market, but also paves the way for products to enter the markets of MDSAP member countries such as the United States and Japan, greatly simplifying the registration process.
REG1A serum reagent: a new tool for accurate diagnosis
This product is the world's first original product to achieve high-risk assessment of precancerous lesions of the digestive tract through blood, filling the gap in the medical field at home and abroad, providing a revolutionary tool for the early detection and prevention of gastrointestinal diseases, and has significant clinical value and economic benefits.
01 High sensitivity and specificity
The sensitivity 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 high-risk groups that really need digestive endoscopy. It greatly improves the early detection rate of diseases and effectively reduces missed diagnosis and misdiagnosis. REG1A alone can be used to detect gastrointestinal mucosal damage lesions (inflammation, ulceration, gastric cancer, bowel cancer).
02 Non-invasive, convenient, and high compliance
The whole process is non-invasive and painless, and patients do not need to bear the pain and psychological pressure caused by traditional examinations, which greatly improves patient acceptance and compliance, and helps to carry out large-scale screening.
03 Fast and efficient with reliable results
The expression of REG1A in serum was detected by enzyme-linked immunoassay. The detection process is simple, the operation time is short, and an accurate test report can be issued within 2 hours.
04 Wide range of clinical application value
It is not only suitable for early screening of gastrointestinal diseases, but also can be used for the monitoring of disease treatment effects, prognosis evaluation and other links, providing comprehensive and dynamic information for clinicians to formulate personalized treatment plans.
Based on a new starting point, start a new journey of global strategy
Looking forward to the future, Shenzhen Shengbo will take this opportunity to obtain Canadian access qualifications to continue to increase investment in R&D and innovation, and continuously improve product quality and technical level. The company will actively integrate global resources, strengthen cooperation with top international scientific research institutions and enterprises, and strive to become a globally competitive life science and technology leader. It is believed that with the joint efforts of all Shengbo people, the company will shine more dazzling on the broad stage of life science and technology and make greater contributions to the cause of human health.