Breaking the import monopoly, domestic diagnostic reagents have made significant breakthroughs in the field of homogeneous chemiluminescence technology

The 2024 Annual Conference of Chinese Medical Association Laboratory Physicians and the 18th National Conference on Laboratory and Clinical Studies (CCLM), hosted by the Chinese Medical Association and the Laboratory Physicians Branch of the Chinese Medical Association, was recently held in Wuhan. The conference focuses on the latest progress and clinical applications of in vitro diagnostic technology, aiming to promote innovative development of diagnostic technology in China and improve the level of medical services.

In vitro diagnosis, as an important means of modern medical diagnosis, is of great significance for early detection, accurate diagnosis, and treatment planning of diseases. However, for a long time, the in vitro diagnostic market in China has been dominated by foreign enterprises, especially in the field of chemiluminescence immunodiagnosis. Domestic brands have been facing significant challenges in technological breakthroughs.

At this conference, Shanghai’s IVD leading enterprise Kemei Diagnostics (688468. SH) released two new nano homogeneous chemiluminescence products – LiCA ® AT5000 and LiCA ® α AT has broken the monopoly of imported reagents in the field of homogeneous chemiluminescence technology, marking a significant technological breakthrough for China in this field. With the development and application of more domestically produced diagnostic reagents, China’s in vitro diagnostic market will gradually achieve independent and controllable development.

Domestic diagnostic reagents break the import monopoly

In vitro diagnosis refers to the products and services that obtain clinical diagnostic information by testing various body fluids, cells, tissue samples, etc. outside the human body, in order to determine diseases or body functions. Internationally, it is collectively referred to as IVD (In Vitro Diagnosis).

Zhu Yuqing, Director of Shanghai Clinical Laboratory Center, introduced that in recent years, China has developed a large number of standard procedures, methods, and substances for the establishment, introduction, and promotion of routine in vitro diagnostic projects, and has achieved remarkable results in standardization work. However, with the deepening of scientific research and clinical practice, the number of in vitro diagnostic projects is increasing, and there are still shortcomings and weaknesses in standardization and reference materials that need to be addressed urgently. However, with the efforts of Chinese companies, this situation is constantly being broken.

Li Lin, Chairman of Kemei Diagnostics, said, “We have been committed to developing diagnostic reagents with independent intellectual property rights, breaking import monopolies, and improving the overall level of domestic diagnostic technology. The release of these two new products is a concentrated display of our technological innovation achievements and a strong response to the domestic in vitro diagnostic market.”

For patients with non ST segment elevation myocardial infarction (NSTEMI), Professor Zhao Hu from East China Hospital affiliated with Fudan University in Shanghai launched a joint detection protocol for high-sensitivity troponin hs cTnI and hs cTnT at this conference, with a focus on LiCA ® The application value of combined detection of high sensitivity troponin hs cTnI and hs cTnT in the diagnosis and treatment of NSTEMI patients. The application of this plan not only improves the accuracy and timeliness of acute myocardial infarction diagnosis, but also provides more comprehensive diagnostic information for clinical doctors, helping to develop personalized treatment plans and filling the gap in the research of domestic diagnostic reagents in the diagnosis of myocardial biomarkers.

“Compared to international giants, we can have products of the same quality or even better,” Li Lin, Chairman of Kemei Diagnostics, told a reporter from First Financial News. “From the beginning of the company’s establishment, we planned to surpass multinational companies to produce first-class diagnostic products. Therefore, we have been working closely with clinical doctors, mastering frontline clinical needs, and transforming technology into high-performance products.”

Domestic brands break through technological difficulties

According to the different detection principles and methods, in vitro diagnosis can be divided into biochemical diagnosis, immune diagnosis, molecular diagnosis, microbiological diagnosis, blood diagnosis, on-site immediate detection (POCT), etc. Immunodiagnosis refers to the qualitative or quantitative diagnosis based on immunology, utilizing the specific reaction of antigen antibody binding. It is widely used in various fields such as hepatitis, sexually transmitted diseases, tumors, metabolism, cardiovascular diseases, infectious diseases, and eugenics.

The “2024-2029 Survey on the Development Prospects and Investment and Financing Strategies of China’s Immune Diagnosis Industry” released by the China Academy of Commerce shows that the size of China’s immune diagnosis market reached 30.86 billion yuan in 2023, a year-on-year increase of 10.4%. According to its prediction, this size will increase to 33.73 billion yuan in 2024.

As the main sub field of China’s in vitro diagnostic industry, chemiluminescence immunodiagnosis has long been dominated by European and American in vitro diagnostic enterprises, especially in small molecule immunoquantitative projects with high difficulty in developing traditional chemiluminescence methodologies. Domestic brands find it difficult to overcome technical difficulties. Domestic enterprises that want to conquer this blue ocean market and conquer core technologies are undoubtedly the key to truly replacing multinational giants.

Komei Diagnosis LiCA ® AT 5000 and LiCA ® α The AT assembly line is the first fully automated immune assembly line based on nano homogeneous chemiluminescence. Li Lin told reporters that the research and development of the machine took about five or six years, but manufacturing is more difficult than research and development. The difficulty lies in how to manage various changes in various manufacturing processes. “There are more than 2000 components in a machine, and we have arranged a large number of professional personnel for quality control in our manufacturing process, which is very crucial.”.

Experts attending the meeting generally believe that the technological breakthrough of Kemei Diagnosis is a significant breakthrough in the field of homogeneous chemiluminescence technology, which is of great significance for promoting the development of the domestic in vitro diagnostic industry. “The application of this technology will not only further improve the accuracy and sensitivity of test results, but also provide new solutions for reducing test costs and improving test efficiency.” Professor Yang Ximing from Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine said, “While improving diagnostic accuracy, reducing test costs is also a major challenge facing the current laboratory. With the continuous progress of medical technology and the increasing richness of diagnostic methods, test costs are also constantly increasing. How to reduce test costs and improve test efficiency while ensuring diagnostic quality is a problem that needs to be deeply considered and solved.”