The Annual Report of China IVD Industry 2021 Part I-V General development trends of future technology and products

5.6  New markers and new inspection items

There are many clinical needs for diagnosis and confirmation of the diagnosis of diseases. The country's annual investment in the field of basic science promotes the discovery and development of new markers by the research team, resulting in the continuous advancement of basic research.

The research team of the State Key Laboratory for Quality Research of Traditional Chinese Medicine of Macao University of Science and Technology has successfully designed the first TiO2-PGC chip in the world. Its extremely sensitive analytical technique can detect minor changes in the trace sugar chains of glycoproteins in complex sugar chains. The researchers analyzed the immunoglobulin in human serum and the serum of patients with rheumatoid arthritis (RA) with this innovative technology, and found that there were 21 diagnostic markers that could distinguish RA patients, among which, the specificity and sensitivity of the combination of two sulfonated N-glycan markers in diagnosing RA were about 85%, and it could differentiate RA from ankylosing spondylitis and osteoarthritis. This was an important breakthrough in the field of glycomics and rheumatoid arthritis diagnostics, which has provided a good technical platform for the in-depth study of glycomics.

A research team of Yokohama City University in Japan announced that it had jointly developed new diagnostic markers for ovarian clear cell carcinoma. Through analysis of protein components, it was found that ovarian clear cell carcinoma would characteristically produce TFPI2, in the hope of providing an effective reference for future diagnosis and treatment through the joint examination of "TFPI2" and existing ovarian cancer markers.

Innovative technology. As IVD has a wide range of application scenarios and involves many techniques, and many detection needs have not been met, a variety of new technologies will continue to be developed, such as digital PCR systems, microfluidic chips, gene editing technology, non-invasive Blood Glucose Monitoring technology, intelligent wearables, third and fourth generation sequencing, etc.

In China, some manufacturers have obtained registration certificates for digital PCR instruments, however, no testing reagent has obtained registration certificate yet. Therefore, the market has not realized the advantages of digital PCR systems. There are various types of microfluidic chips, but until now, none of them has created a mainstream application scenario. All conditions above bring a lot of development potential to IVD enterprises. As a gene editing technology that has won the Nobel Prize, it is expected by everyone to generate specific products and application scenarios, bringing new surprises to the IVD industry. Although the Continuous Glucose Monitoring system is developing rapidly, the real non-invasive glucose monitoring system has not yet appeared. It is believed that with the continuous development of science and technology, the launch of non-invasive glucose monitoring will bring about a revolution in glucose monitoring.

The demand for intelligent wearables is increasing, and the relationship between manufacturers and end users has changed significantly. With the help of intelligent information, clinicians improve diagnosis, monitoring and prevention of diseases. At the same time, patients also avoid unnecessary visits. Both patients and consumers can obtain valuable advice on lifestyle and diet. In the context of increasing chronic diseases and aging, preventive and personalized care has become a new treatment. Those technologies that can support patients' behavior changes and bring positive changes in patients' lifestyles will be in high demand in the future.

The third-generation sequencer and the fourth-generation sequencer can complete single-molecule sequencing and direct RNA sequencing. After more than 10 years of development, the research on gene expression regulation based on single cell is gradually becoming mainstream. In third-generation sequencing, gene sequencing is studied in two dimensions of time (cell cycle) and space (organ distribution) with a single cell as a unit to record the mechanism details of gene expression regulation of cells in the original tissue. The fourth-generation sequencer can directly sequence RNA molecules at the single-cell level and single-molecule resolution, and recognize the modified nucleotides not directly transcribed in the sequence. Therefore, the fourth-generation RNA direct detection technology must simultaneously utilize nanopore technology and on-chip Raman spectroscopy, which has the characteristics of fast sequencing and real-time monitoring of sequenced data.

Gene editing technology CRISPR: The gene editing technology CRISPR is on its way to commercialization. The latest progress in genetic engineering has started new changes in biological and translational applications. CRISPR-Cas9 and its variants can perform multiple operations on genome functions. This genome editing covers almost all industries involving biological systems, mainly including biotechnology, agricultural technology, therapeutics and diagnostics. A wide range of products in the biotechnology market, including CRISPR-Cas9, provide the required endonuclease and gene editing reagents. At present, CRISPR technology is still in the research stage in the diagnosis field. A lot of development work is still needed before the diagnostic test based on CRISPR technology can be used in practice. Today, only a few key institutions are committed to the diagnostic applications of CRISPR technology.

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