Second-generation sequencing technology is gradually applied to tumor dynamic detection The domestic potential market size is nearly 100 billion

High-throughput gene sequencing (NGS), also known as second-generation sequencing technology, has played an important role in the global fight against COVID-19, and has greatly improved the throughput and discovery speed of research, and has also driven multi-omics research to benefit human life and health.

Earlier this month, the first and most complete sequence of the human genome was announced to date, a $3 billion initiative that provides a firm foundation for precision medicine, especially for diagnostics, new drug development and the exploration of new therapies in the field of oncology.

Li Qing, senior vice president of Illumina and general manager of Greater China, told the first financial reporter in an interview on April 10: "The NGS market has broad prospects, tumors are a very important application in the field of NGS, and promote the rapid growth of the NGS market. ”

The molecular level "sees" tumor cell residues

Li Qing said that the growth of the NGS market mainly comes from two aspects, on the one hand, tumor screening, on the other hand, the dynamic detection of tumor micro-lesion residue (MRD).

In terms of early tumor screening, many genetic testing companies have emerged in China. For example, the domestic single-cell diagnostic company Junhui Bio applied the liquid biopsy method to the early screening of bladder cancer.

Liquid biopsy plays a huge role in the diagnosis and treatment of tumor patients. Liquid biopsy is noninvasive compared to tissue testing and offers innovative advantages such as disease monitoring and treatment monitoring of patients.

Li Qing believes that MRD is an important direction for the future development of NGS. He said that in the future, through the means of liquid biopsy, it is also possible to determine the residual tumor cells, which involves whether the patient needs to receive adjuvant therapy, including whether some radiotherapy and chemotherapy regimens need to be adjusted in the future.

He said that the pathology of traditional surgical specimens can only see 5% of tumor cells, while the molecular diagnostic level NGS detection can see a level of one in a million, so with the help of NGS methods, tumor recurrence can be found earlier and more clearly.

In the United States, biotechnology companies including Guardian and Grail have entered the MRD market. According to JPMorgan Chase's estimate of the global liquid biopsy potential market, the total market for MRD in the United States is expected to reach $33.6 billion, and some products are already included in Medicare. "Now many companies in the United States have begun to buy sequencers in large quantities, just to expand the MRD market." Li Qing told the first financial reporter.

He analyzed that according to the similar medical population in the United States, if the domestic MRD test price is calculated according to 1/3 of the United States, then the total potential market volume of China's MRD is expected to be close to 100 billion yuan. Li Qing told the first financial reporter: "The future of domestic MRD is a big market, and this market will sink in the future, which is a very important therapeutic value and development direction of MRD." ”

He also said that the detection of MRD is based on the second-generation sequencing technology of blood DNA, which requires powerful algorithms and big data analysis, which is more technically difficult for many domestic companies.

The value of clinical therapeutic interventions has yet to be verified

The development of the MRD market in China in recent years is also very rapid. Last year, the mainland has reached the first "Lung Cancer MRD Detection and Clinical Application Consensus", including stone-burning medicine, Nanjing Shihe, Shanghai Mind Di and Beijing Zhenhe and other enterprises all admitted, in the lung cancer, bowel cancer MRD product development and clinical verification have made important progress, can detect the recurrence of tumor patients at a very early stage.

Companies said that it remains to be verified how much NGS can benefit patients in clinical applications. Han Yusheng, founder and CEO of Burning Stone Medicine, told the first financial reporter: "At present, most of the NGS that most people know focuses on concomitant diagnosis, but in the field of MRD detection and early detection of multiple cancer species, it is still in the early stage of commercialization. ”

Mao Mao, founder of genetic testing company Siqin Medical, told the first financial reporter: "The sensitivity of MRD detection and the related costs are still a big challenge for the development of this technology, and we also hope to develop a MRD detection method with more cost and higher accuracy." ”

Professor Zhang Xuchao, director of the Guangdong Institute of Lung Cancer, reminded that MRD testing should be used rationally. He told the first financial reporter: "At present, MRD has not been applied to the clinic on a large scale, because we must consider that MRD must bring clinical benefits to patients; MRD detection also involves many details that need to be improved at the technical level, and we must identify good MRD detection technology through clinical research." ”

Professor Lu Shun, director of the Department of Oncology of the Chest Hospital affiliated to Shanghai Jiao Tong University, also said publicly: "So far, MRD research is only as an indicator of tumor prone recurrence and metastasis to provide prognosis or prediction, and there has not been a study to intervene in this detection result, so whether the intervention can change the outcome after the intervention is a topic that everyone is more interested in now." ”

Yan Zhuohui, founder and CEO of Junhui Biology, told the first financial reporter: "MRD is a hot area of NGS application at present, and many domestic companies are doing clinical research. This test detects free DNA in the blood to find out if there are any residual tumor foci in the patient, but will intervention based on the results of these residual lesion detection have an effective effect on the patient? Many clinical studies are also being conducted. ”

Yan Zhuohui believes that after the value of MRD testing for clinical therapeutic interventions has been verified by large-scale studies, it is possible to carry out large-scale promotion and application in the clinic. "We are now testing tumor cells and genes in the blood, planning large clinical trials, and also hoping to understand the remaining lesions and the risk of metastasis, which is consistent with MRD testing from this goal." He told the first financial reporter, "The ultimate goal is to hope for early detection and treatment, and greatly extend the survival of patients." ”