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In 2015, China's early tumor screening industry started to take off
.
From 2015 to 2019, the early tumor screening industry is in a period of steady development, and the technology is gradually mature and perfect, and several auxiliary diagnostic products have entered the market one after another
In 2021, the early tumor screening track will continue the momentum of rapid growth in 2020
.
In the first half of the year, the first domestic listed company with early cancer screening business as its core source of income was born.
From January 1 to July 31, 2021, the financing situation of early tumor screening companies
However, it can also be seen that the competition in the early tumor screening track is becoming increasingly fierce.
Some industry sources said: "2021 is the year of early tumor screening
.
" In this case, creating a differentiated competitive advantage becomes crucial
The "discrimination power" of tumor targets is the soul of enterprise development
The "discrimination power" of tumor targets is the soul of enterprise development With the large-scale commercialization of Cologuard and the diversified product development capabilities of self-research + mergers and acquisitions, Exact Sciences has become one of the most successful early tumor screening companies in the world
.
In the no-man’s land where early tumor screening technology is developed, the success of the company is inseparable from the diversified product line layout and the construction of early tumor screening platforms, especially the ability to detect targets
At present, early tumor screening products are mainly divided into (1) algorithm interpretation of target panel; (2) specific target detection
.
Among them, target-specific detection has increasingly become the mainstream detection method for early tumor screening products
(1) Algorithm interpretation of target panel; (2) Specific target detection
If they do not have the ability to discriminate targets, companies will find it difficult to make progress when facing cancers that have no international reference targets
Over the years, many targets that are closely related to the occurrence and development of esophageal cancer, liver cancer, gastric cancer, bladder cancer, and pancreatic cancer have been discovered.
In terms of product layout, Emison has carried out a diversified product layout in the early screening of digestive system tumors, gynecological tumors, urinary system tumors and pan-cancer types: Among them, in terms of digestive system tumors, Emison has deployed colorectal cancer, esophageal cancer, Liver cancer, stomach cancer, and pancreatic cancer are the five major cancer types.
Cervical cancer and endometrial cancer are deployed in gynecological tumors, and they have a leading advantage in the completeness and richness of the product pipeline
.
Emison's diversified product layout
For accurate target diagnosis, Ai Changkang under Emison has innovatively adopted double-methylated target detection technology
.
The dual-target product has a high Youden index.
Double methylation target detection technology
Product IVD is a necessary condition for the long-term development of an enterprise
Product IVD is a necessary condition for the long-term development of an enterprise There are two forms of income from early tumor screening products: LDT and IVD
.
LDT refers to the provision of testing services, and IVD refers to reagent products that can only be sold after they have been approved by regulatory agencies such as NMPA and FDA
.
LDT is the model adopted by most early tumor screening companies
.
Compared with the IVD model, LDT can reduce the time for regulatory approvals, quickly enter the market, and generate sales revenue
.
However, it needs to be clear that LDT can only serve a small number of patients, which is contrary to the original intention and concept of early tumor screening.
At the same time, it is affected by issues such as regulations, cost, and quality control, which determines that LDT is difficult to exist as a mainstream model for a long time
.
Judging from the past experience of domestic tumor early detection products, Helicobacter pylori detection, HPV detection, TCT detection, tumor markers and other products are all promoted in the market in the form of IVD
.
IVD products are the road to breaking the situation for the long-term development of enterprises , and enterprises should realize the leap from LDT to IVD as soon as possible
.
.
Enterprises should realize the leap from LDT to IVD as soon as possible
.
It can be clearly noticed that some companies have put IVD on the agenda recently
.
"
Obtaining the certificate is only the first step.
Whether the product meets the actual clinical needs is the key to its successful implementation .
" Zhang Lianglu pointed out, "We understand that to successfully implement the clinical application on a large scale, it needs to have four characteristics at the same time.
Nothing: Compliance, Accuracy, Inclusiveness, and Convenience
.
The first is compliance.
The product complies with the National "In Vitro Diagnostic Reagent Registration Management Measures".
Through reasonable design of clinical research, it has obtained the approval of the State Food and Drug Administration for the listing of Class III medical devices
.
At present, some products are technologically advanced, and they will encounter greater challenges when designing reasonable clinical studies or regulatory approvals
.
The second is precision.
Good products not only have high detection accuracy, but also can accurately locate clinical pathways
.
The higher the detection performance of early cancer or precancerous lesions than other clinical products, the more obvious the clinical significance, and the more conducive to clinical promotion; at the same time, as a new diagnostic product, it can clarify the clinical positioning and compare with the existing diagnosis.
Forming complementary diagnosis and treatment by doctors is also an important basis for clinical application
.
The third is inclusiveness.
Early tumor screening products mainly serve asymptomatic groups or high-risk groups, with a very large population base and high price sensitivity
.
Therefore, the market price should be relatively friendly, and only when the people buy it can the product benefit the whole people
.
Companies with better product cost control will have the opportunity to maintain a lasting competitive advantage in the future Red Sea competition
.
The fourth is convenience.
At present, most tumor screening products are non-invasive or minimally invasive, which effectively improves patient compliance; but the key point is that for medical technicians who operate in large quantities every day, the convenience of operation is the same.
Important
.
Current tumor screening products often do not consider the operation scenarios of front-line personnel.
The complicated operation methods and redundant detection procedures discourage medical technicians in medical institutions, which seriously affect the promotion of products.
The convenience of product operation has become the most important for early tumor screening companies.
One of the important competitive points of differentiation
.
Emison has always adhered to the orientation of serving medical institutions and the concept of early cancer screening to benefit the public
.
On the premise of meeting the needs of clinical diagnosis, we will continue to improve product testing throughput, shorten testing time, and enhance the automation from sample pre-processing to testing results, and is committed to turning the special early-screening tumor screening project into a general inspection project for medical institutions
.
At the same time, the localization of reagent raw materials and the self-production of supporting reagent products have been
realized , effectively controlling product costs .
The cake of early tumor screening is not big, but it is very thick.
To be able to cut this big cake, companies must not only have a sharp "knife", but also have craftsmanship and long-lasting endurance
.
.
The localization of reagent raw materials and the self-production of supporting reagent products have effectively controlled product costs
.
The role of industrial capital in helping tumor early screening companies will gradually become prominent
The role of industrial capital in helping tumor early screening companies will gradually become prominent Capital is one of the important forces driving the rapid development of the tumor early screening industry.
In 2020, a number of large-scale financings have ushered in the industry's first climax
.
As of July 2021, the total financing amount of the early tumor screening track has exceeded tens of billions
.
As one of the domestic companies in the early stage of the tumor screening industry, Emison has naturally received wide attention from investment institutions
.
In 2017, the company won the investment of Cap Biotech, a leading domestic cervical cancer screening company.
In 2020, it will complete the A round of financing of the CCB Medical Growth Fund investment.
Kaipu Biotech invested nearly 100 million yuan in Series B financing
.
It is worth noting that the two leading IVD companies of Cap Biology and Golden Mile Medical are both investors of Emison
.
The difference between the criteria for selecting investment targets for industrial capital and financial capital is that industrial capital
pays more attention to the true value and clinical applicability of the product, and regards the clinical applicability of the product as the core standard for long-term investment .
"At that time, Cap Biosciences and Golden Mile Medical both conducted multiple rounds of tests on Emison’s early colorectal cancer screening and cervical cancer early screening products, and finally recognized Emison’s R&D capabilities, product performance and clinical landing capabilities, and then decided to invest.
.
"
.
Next, as early tumor screening enters the stage of commercialization, the role of industrial capital in channel, marketing, customer resources and other aspects of supporting enterprises will gradually become prominent
.
It is foreseeable that relying on industrial capital such as Kaipu Biotech, the clinical implementation of Emison's products will be smoother
.
.
The enthusiasm of capital for early tumor screening will not cool down in the short term, and will continue to heat up
.
Driven by capital and corporate parties, the industry will maintain rapid growth for a period of time
.
However, it is necessary to be wary of overheating and blind investment.
The risk of rapid cooling of industries with excessive heat is also higher, which is not conducive to the healthy development of the industry
.
The capital must first clarify that the future of early tumor screening must be IVD
.
Next, investment institutions should break away from the thinking of measuring corporate value purely from the perspective of technology and clinical trials, but pay more attention to and verify whether products meet actual clinical needs
.
Enterprises should also make it clear that capital is only a help.
The more enthusiastic the capital, the more the company has to calm down, cultivate internal skills, and polish products
.
I believe that as more and more products that meet clinical needs realize IVD, investment institutions will become more rational, and the industry will enter a stage of benign development
.
.
Enterprises should also make it clear that capital is only a help.
The more enthusiastic the capital, the more the company has to calm down, cultivate internal skills, and polish products
.
At present, Emison has launched a new round of financing, which will be used to expand the market and conduct new product development, registration and prospective clinical trials
.