In recent years, China has continued to make efforts in the field of technology, and as a result, the in vitro diagnostics (IVD) industry has ushered in new development opportunities. Both research teams formed by overseas returnees and locally trained technical elites are committed to promoting the development of IVD technology. Especially with the advancement of emerging technologies such as artificial intelligence, the emergence of representative technologies like DeepSeek has brought new vitality to the IVD industry. However, despite the emergence of innovative technologies, there are still significant obstacles between laboratory results and clinical practical applications.

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The gap between technological innovation and clinical practice

At the recently held 14th National People's Congress, Sun Jian, president of Nanfang Hospital of Southern Medical University, emphasized the challenges faced by the application of new IVD technology in clinical practice. He pointed out that although IVD technology has great potential in disease diagnosis, treatment, and monitoring, its productization process from research and development to commercialization is time-consuming, costly, and complex, especially with low market returns, which seriously hinder the popularization and application of advanced technology.

Especially in the research and development of detection technologies for rare and difficult diseases, the above-mentioned issues are even more pronounced. Due to the small patient base of these diseases, the market attractiveness is insufficient, and companies often lack the enthusiasm to promote these technologies to the market. Sun Jian suggested that high-level medical institutions should actively promote the "Laboratory Self built Testing Method (LDT)" to accelerate the transformation of testing technology into clinical applications and benefit patients as soon as possible.

Launch of LDT pilot work

LDT refers to IVD reagents developed and used by medical institutions based on their own clinical needs. Compared to traditional IVD products, LDT enjoys a more flexible approval process and can quickly introduce innovative technologies into clinical practice. In 2022, the Drug Administration and the Health Commission jointly issued a notice on the pilot work of independently developing and using IVD reagents in medical institutions, marking the official launch of the LDT pilot work.

Medical institutions participating in the pilot program usually have strong research capabilities, can independently develop new diagnostic tools based on clinical needs, and establish corresponding standardized processes and quality control systems. These types of institutions aim to serve clinical practice rather than pursuing profit maximization, and quickly provide cutting-edge and effective testing methods to patients through LDT. This not only accelerates the application speed of technological innovation, but also explores a new development path for the entire IVD industry.

Difficulties in profit distribution and technological updates

Nevertheless, LDT has opened up a new path for the clinical application of IVD technology, but there are still challenges in terms of benefit allocation and technological updates. The lifecycle of IVD products is relatively short, with fast technological updates. According to conventional approval and industrialization processes, it takes several years. During this period, the approved technology may become outdated, which can affect the enthusiasm of the enterprise.

To address these issues, representatives proposed that companies work together to optimize the mechanism of benefit distribution and ensure that innovative technologies receive the market recognition they deserve. At the same time, the approval process should be simplified to shorten the time interval from research to clinical practice, so that patients can benefit from new diagnostic technologies in a timely manner.

Outlook for the IVD industry

Despite facing numerous difficulties, the IVD industry is gradually emerging from the pressures of centralized procurement, insufficient productivity, and disorderly market competition, demonstrating new vitality and development models. IVD companies need to continue to uphold the spirit of saving lives and helping the wounded, and promote the advancement of diagnostic technology for rare and difficult diseases.

As a member of the IVD field, Desheng New Materials continuously strives in scientific research capabilities and technological innovation. Its developed chemiluminescent reagents, chromogenic substrates, and other products have injected vitality into the inspection and testing industry. Desheng New Materials hopes to contribute to the cause of human health through these innovative achievements.