Heshine launched multi -cancer early screening products to cover six high -risk and high -risk cancers

Economic Observation Network reporter Qu Yixian on June 23rd, tumor gene testing enterprise and Richitan announced the launch of multiple cancer early screening products "Quan Sining", which is based on the development of HIFI technology system with Richita. , Stomach cancer, liver cancer, pancreatic cancer, and colorectal cancer 6 major high -risk high -risk cancers.

Zhou Yan, CEO of Ruken, said that these six cancers are the six highest risks and the highest mortality rates in China, covering 60%of Chinese new tumor patients each year, and some of them do not have a good screening plan at present.

"We take the lead in verifying that this path is feasible through liver cancer. Through research and data proof, we find that we can extend from the liver to the lungs, and now extend to more 6 cancers. Considering the characteristics of Chinese tumor epidemiology at the same time, the release of 'Quan Sining' also marked us to extend from 1 to more. "Zhou Yan said.

From 1 to 6

In May 2022, the National Development and Reform Commission issued the "Fourteenth Five -Year Plan" Biological Economic Development Plan, which is the first five -year plan for the biological economy in China. It proposes to promote the in -depth integration of advanced technologies such as genetic testing and disease prevention. Early screening of major diseases, thereby providing precise solutions and decision support for individual chemical treatment.

Single cancer screening technology for a tumor logo has been popularized in some diseases, such as nail protein in liver cancer screening, and then prostate specialty antigen.

The innovative liquid biopsy technology based on the NGS platform has greatly increased the possibility of early cancer discovery. Compared with cancer screening methods such as traditional tumor logo and imaging, innovative early screening products of the liquid biopsy, on the basis of the great improvement of the overall detection performance, also have the advantages of non -invasive and simple samples, which can greatly improve high risks Civil screening is based on the adult, and strives to greater clinical intervention windows for early cancer patients and improves the survival rate.

"Quan Sining" is also a liquid biopsy early screening product. According to the introduction of Hernes, it is currently the first multi -dimensional sequencing (WGS) technology for multi -dimensional genome sequencing (WGS) technology using free DNA (CFDNA) in the world. Early cancer signals reduced missed examinations caused by individualization and different tumor molecular biology characteristics. The performance reached 87.58%of the sensitivity, 99.09%of specificity, and 82%traceable accuracy.

In addition, "Quansin" is developed based on the HIFI technology system independently developed by Rocky. The HIFI technology system can iterate and optimize itself, continuously optimize performance, reduce product research and development and detection services, so that the cost of multi -cancer early screening technology can be available. Control and price can be available.

In Zhou Jun's view, liquid biopsy is a big wave of technology. Its technical potential can achieve early discovery of cancer, and can continuously optimize itself. From 1 to more, this is also the attention of the United States and China to enter the liquid biophay Reasons for the field.

"From 1 to more" refers to the screening from single cancer screen screening to multi -cancer screening, and the latter has put forward higher requirements for the sensitivity, specificity, and so on.

Zhou Jun said that the approach of Her Ribin is: first use a single cancer to verify this method, and then expand it with caution. Each cancer requires a set of research and experiments to prove it with the existing screening methods. Compared to better performance.

In August 2020, the first clinical -level liver cancer early screen product "Laisin" was listed in Hekin. Since then, through the whole gene

Group sequencing and corresponding analysis algorithms, establishing early warning prediction models, and gradually forming the HIFI technology system.

"It looks like it has changed from 1 overnight to 6, but in fact, we have accumulated a lot of data behind us in recent years. Why not 1 to 8, 1 to 10, because I think these 6 cancers are feasible, clinical high -risk and high incidence of incidence There is enough demand, and at the same time our data can be delivered. "Zhou Yan said.

Zhou Yan pointed out that there is also a unique feature of multiple groups of early screening products, because the more data is related to the data, when the detection is more, the dimensions of observation are large, and the amount of data will be more. In turn, it will help the product itself improve performance Essence

commercialize

For the tumor gene sequencing industry, the current mainstream supervision method internationally is in accordance with the LABORATORY Developed Test, laboratory self -research detection) supervision.

The latest revised "Regulations on the Supervision and Administration of Medical Devices", which was implemented from June 1, 2021, clearly stated that "there is no in vitro diagnostic reagent for domestic products listed in China, and qualified medical institutions can develop themselves according to the clinical needs of their units. Under the guidance of practicing physicians, use in this unit.

This is the first time that the LDT model has given legal identity at the level of laws and regulations. From the perspective of laws and regulations, it supports innovative testing projects such as NGS tumors with third -party testing as the main business model.

Including Richita, most domestic tumor gene testing companies are two ways in parallel. In addition to the LDT model, there is also a model as a drug and equipment to take IVD (in vitro diagnostic) product approval path.

Zhou Yan believes that in the future, as more and more genetic testing products enter the hospital and enter the public, IVD products and LDT will provide precise medical services in parallel, and Ruishine will also maintain the LDT and IVD parallel mode mode Essence

Multi -cancer products are very different from single cancer products. They are mainly different from the crowd. Usually, single cancer products are facing high -risk people for a certain kind of cancer. What's more important is to face healthy people, so they have proposed new tests on their product performance and commercialization. There are more successful examples abroad.

Grail, an American Cancer Early Sieve, has always focused on screening most of the early cancer detection methods through a single blood -drawing pan -cancer, that is, developing multi -cancer screening products. In June 2021, Grail's Galleri was listed in the US market.

According to Grail's description, through a doctor's prescription, Galleri is used for cancer screening of asymptomatic people over the age of 50 as a supplementary method for the existing single cancer screening method. In previous observation research, the product was based on testing blood. CFDNA methylation, one time can detect more than 50 cancers.

The Grail's prospectus shows that the number of Galleri target users is expected to be about 52 million. At the unit price of $ 1,400, the penetration rate of 1%is estimated, the first year of Galleri will have more than $ 700 million in revenue.

Guoyuan Securities calculated that in 2030, the market space of China's liver cancer was about 10.65 billion yuan, and the potential market space of colorectal cancer was about 9.6 billion yuan.

This is just two cancer -sieve market space. If it is 6 cancer species, the market space is undoubtedly huge.

Zhou Yan thought about the channels of cancer early screening products very early. In his opinion, there are several characteristics in the domestic market: first, the tumor is very serious, so the ultimate destination is clinical; second, China's clinical clinic must be around public hospitals or core hospitals.

Therefore, it also had the focus of the previous cancer products with Ritarian -let clinical experts see, accept, and recognize the contribution of this new technology to early screening. Whether it is single cancer or more cancer, "closer to the diagnosis and early diagnosis, it is naturally combined with clinical clinical."

Regarding the pricing of "Quansin Ning", Zhou Yan expressed that "hopes to be a state of a hundred yuan costs a thousand yuan price", and as for how much cost can be reduced, it takes time and technology to demonstrate. Technological progress is achieved.

"The pricing of multi -cancer early screening products is not simply added to the pricing of each single cancer early screening product, but to combine the overall health economics elements such as the overall onset, clinical benefits, and the burden of the public. And proved that the value of health economics is still a problem faced by the entire industry. "And Richita stated to the Economic Observation Network that in foreign countries, head companies, such as Grail Value in the medical system. The accumulation of these evidence plays a key role in promoting payment institutions such as medical insurance and commercial insurance into a liquid biopsy for early screening products or services.

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