foreword
In recent years, with the rise of targeted therapy and immunotherapy, precision medicine has gradually entered people’s field of vision. Targeted drugs and immunotherapy drugs have created anti-cancer myths with unprecedented precision. Precise medicine requires precise diagnosis, and only when the classification is determined can the targeted medicine be prescribed, and companion diagnosis emerges as the times require. Today, companion diagnosis has become an indispensable detection link before medication, and is the core subdivision of in vitro diagnosis, entering the commercialization stage. Companion diagnostics are regulated in policy, a hundred flowers are blooming in technology, and differences are shown in models. The market pattern of companion diagnostics has been formed.
The new vitality comes from the innovation of technology and model. Technically, mainstream technologies such as PCR, IHC, and FISH gene sequencing have been more or less upgraded. Emerging technologies such as single-cell technology, mass spectrometry, and multi-omics technology have shown new energy. “gold standard”? In terms of model, LDT has started to be implemented as a pilot in hospitals, the overseas market has grown significantly, there are few attempts at the grassroots level, co-construction of laboratories is full of controversy, and joint development with pharmaceutical companies is gradually emerging. What is the development logic of each model? What’s next?
With questions in mind, we communicated with more than 15 companies and nearly 30 experts, and wrote the “2022 Companion Diagnostics Industry Research Report”, which mainly discusses the application status and future trends of companion diagnostics in the field of tumors. In terms of technology, model and payment, we draw the following conclusions:
In terms of technology, mainstream technologies and emerging technologies are jointly promoted. PCR and gene sequencing have been upgraded to three generations, and mIHC can achieve multiple markers and rapid FISH hybridization faster. Single-cell technology interprets analysis from the dimension of cells, and mass spectrometry is an important analytical technique in the field of biomacromolecular research. In the future, multi-technology and multi-omics platforms will jointly promote the development of the industry, and at the same time, AI will empower the closed loop. In addition to meeting the basic characteristics such as sensitivity and stability, the successful clinical application of technology can also measure the potential of technology application in five dimensions: standardization, simplicity, throughput, technology cost, and talent cost.
In terms of model, LDT admission is the threshold, and there are differences in recognition. Domestically, the threshold is established in the form of LDT entering the hospital instead of setting up an approval path. Whether it is a co-construction laboratory or a model of cooperation with pilot hospitals, LDT entering the hospital is a barrier. Under the barriers, the approval of products will inevitably be different. The difficulty of obtaining approval for LDT products piloted in third-level hospitals must be less than that of pilots in second-level hospitals or third-party testing institutions. At the same time, where LDT products will be implemented will be a new measurement standard. In terms of the difficulty of supervision, it is easier to implement LDT pilot hospitals in public third-level hospitals at this stage.
In terms of payment, the expansion of medical insurance is accelerating, and PCR may be the first to usher in centralized purchasing. Combining the past developments of the tumor genetic testing project and the response from the National Medical Insurance Bureau on October 12, 2022 to its inclusion in medical insurance and mass purchases, we believe that in the long run, the inclusion of tumor genetic testing in medical insurance will benefit the development of companion diagnostic projects. development of the hospital. In the short term, due to the high cost of NGS and the high R&D cost of large panels, it may be difficult for medical insurance to cover it. At the same time, PCR is widely used, relatively mature, and low in cost, and may be the first to usher in centralized procurement.
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