[Transfer] Tumor liquid biopsy for ten years, who has been empty with this "rocket"?

[Transfer] Tumor liquid biopsy for ten years, who has been empty with this "rocket"?

Source: amino observation/Huang Kai

In 2010, the Institute of Medical Center of the University of Hamburg published an article entitled "Circle Tumor cells: challenge and prospects" called "Cancer patients" on the Trends in Molecular Medicine. one.

The so -called liquid biopsy is the technology that diagnose the disease through the body fluids such as blood, urine, saliva. Because of the characteristics of non -invasive and comprehensive analysis, we are a great weapon for us to fight diseases.

At present, the most representative of liquid biopsy is our familiar non -invasive prenatal diagnosis product (NIPT). In the past ten years, with the advantages of compliance and performance, NIPT has occupied the C position in the field of Tang's syndrome screening.

The liquid biopsy technology also provides new ideas for tumor diagnosis and treatment. In the more than ten years after publishing the paper at the University of Hamburg University of Medical Center, the development of tumor liquid biopsy technology is as fast as rockets.

Today, this technology has been widely used in many fields such as early screening, accompanied by diagnosis, and prognosis testing. In this regard, some people call it "revolution in the field of tumor diagnosis and treatment."

It is also in this great change that a number of star companies have emerged globally:

Born overseas, giants including Grail, Guardant Health, etc. have a valuation of over 5 billion U.S. dollars. Medical and other leaders.

But even so, the tumor liquid biopsy technology is still "young", and there are many difficulties that need to be overcome. In other words, the tumor liquid biopsy has a large space for flying.

So, who can take empty with it in the future?

/ 01 /

Push the door of the tumor early screening

For tumor early screening companies, we must thank the development of liquid biopsy technology. After all, the technical foundation of the survival of the tumor early screening company is the "liquid biopsy".

Whether it is necrotic, apoptosis, or normal physiological activity, tumor cells will leave traces in the blood, including circulatory tumor cells, circulating tumor DNA, etc.

Taking a circulating tumor DNA as an example, the gap between normal people and tumor patients is obvious. In the plasma in healthy people, the range of circulating tumors is 0 to 100 ng/ml, and the average concentration is 30 ng/ml; in the tumor patient's body, the average concentration can reach 180 ng/m, and up to 1000 ng/ml.

It is these differences that created the possibility of "blood test cancer". The global early screen giant Grail uses the principle of detecting the cycle tumor DNA to develop Galleri, a high -performance pan -species early screening product with high performance.

At present, Galleri can screen nearly 50 kinds of cancers. Although the performance is not perfect, most of the cancer species and early patient detection rates are not high, but it is already a disruptive era product.

Even in the United States, there are only five types of cancer with "gold standards", while the group of patients with these five cancers account for only 29%. In other words, more than 70%of tumor patients have not have a good screening method so far. The emergence of Galleri has brought "better" choice to many patients.

Based on this, Grail's parent company's expected Galleri sales will reach US $ 70 million-90 million for annual sales. In the first year of listing, it is quite good to achieve such results.

Domestic sieve star companies are also based on liquid biopsy technology in the wind and waves. At present, the launching stone burning medicine, pan -child, and Nuohui health have been launched in early screening products based on liquid biopsy.

With the continuous advancement of commercialization, these products are bound to open the imagination of domestic players.

/ 02 /

Confusion accompanied by diagnostic pattern

As a revolutionary technology, the liquid biopsy is not only the field of screening, but also the field of diagnosis.

For a long time, organizational biopsy has been the standard tool for oncology diagnosis and assessment and genome analysis. The so -called tissue biopsy is a means of analyzing from the patient's body to cut, plug or puncture to remove the lesion tissue.

As far as this technology is concerned, there are many disadvantages. For example, poor compliance leads to dynamic monitoring during treatment. More importantly, it is not suitable for some advanced tumor patients. Because these patients may not have enough tissue samples to detect at the molecular level.

Facing the pain points of the organization biopsy, liquid biopsy is undoubtedly a very good supplement. After all, a tube of blood is enough. Because of this, the development of global liquid biopsy in recent years has accompanied the development of diagnostic products from scratch, and it is booming.

At present, the development of overseas companies is leading. Since 2016, the liquid biopsy approved by the FDA has accompanied the technical platform of the diagnostic product. From PCR to NGS, genetic testing has become higher and higher; the target has also developed from the earliest EGFR and Pik3CA to EGFR/BRCA1/2/Pik3CA /ALK, the range of indications is getting wider and wider.

Of course, there is not much behind in China, and the breakthrough is also the first to come from the PCR field. In January 2018, Ed's Super-RMS® EGFR gene mutation testing kit was approved, becoming my country's first accompanying diagnostic reagent based on liquid biopsy technology. In the field of NGS, domestic enterprises represented by Burnom Medicine are also rapidly advancing. Ranshi Medical was recognized by Merck. In November last year, Ranshi Medical announced that Langqing used Merck's oral MET inhibitors TEPOTINIB's accompanying diagnosis registration in mainland China.

Today, although organizational biopsy is still the gold standard for diagnosis evaluation and genome analysis. However, with the development and maturity of liquid biopsy technology, more and more liquid biopsy technology based on the listing of liquid biopsy technology will not have a certain impact on traditional forces.

/ 03 /

Lead MRD monitoring and development

The liquid biopsy has a profound impact on diagnosis and treatment, as well as the field of MRD monitoring.

MRD is a tiny residual lesion, which refers to the existence of residual malignant tumor cells in the body during or after treatment.

The simple understanding is that the content of tumor cells that have escaped after treatment may be minimal, but it may still cause cancer to recur. Therefore, MRDs need to be monitored after treatment of cancer patients to monitor the risk of postoperative tumor recurrence.

MRD testing is not a new concept. In the past, in the treatment of leukemia, detection products based on streaming cytosophy and PCR technology have been widely used.

However, with the development of liquid biopsy technology, physical tumor MRD monitoring has also ushered in breakthroughs. In April 2021, Guardant Health announced that its Guardant Reveal was listed.

The product can detect the patient's residual disease state within 7 days through the method of blood testing, and tumor doctors can be used to identify high -risk recurrence patients in colorectal cancer.

In the field of physical tumors outside the field of colorectal cancer, there are more and more evidence that MRD testing based on liquid biopsy technology can bring better prognosis management to patients.

For this opportunity, domestic enterprises are naturally acting. For example, Panzang is expected to have achieved major milestone progress this year.

Zhenhe Technology announced recently that after preliminary clinical research and technical performance verification, the physical tumor MRD products have been expanded from lung cancer and colorectal cancer to pan -cancer species.

Although MRD testing products of domestic enterprises need to be further verified by large -scale forward -looking clinical research. However, the prospect of MRD testing based on liquid biopsy is obviously no question.

/ 04 /

Summarize

In the past 10 years, liquid biopsy technology has opened up new ways for cancer diagnosis and treatment, providing important clinical opportunities for personalized treatment of tumors. Thanks to this, the diagnosis and treatment of tumor patients has been greatly improved.

However, this does not mean that tumor liquid biopsy technology is very mature. Although this technology has promoted the development of many fields such as early screening, accompanying diagnosis, and MRD testing, there are still many problems that need to be solved, such as improving detection performance.

Through technology and understanding of the industry, it is still the direction that products can continue to be upgraded to meet more clinical without meeting the needs.

In the future, tumor liquid biopsy technology will continue to develop, and the market size will continue to grow. Whoever can do better will undoubtedly open the ceiling with this "rocket".

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