Accurate medical care opens up new trends in the development of DNA sequencing and liquid biopsy in the blue ocean

Release date: 2018-03-29

In Vitro Diagnosis, IVD (In Vitro Diagnosis), refers to products and services that obtain clinical diagnostic information by detecting human samples (blood, body fluids, tissues, etc.) outside the human body to determine disease or body function.

IVD has become an increasingly important part of human disease prevention, diagnosis and treatment, and is an increasingly important part of safeguarding human health and building a harmonious society. Under the general trend of gradual integration of diagnosis and treatment, the diagnostic techniques based on numerator, accompanying and gene of pan-IVD are also booming, and are gradually shifting from scientific research to a broader clinical market.

The traditional IVD market has entered a stable and mature Red Sea competition. Emerging detection technologies and big data must be the industry commanding heights for the future!

Precision medicine brings development opportunities to IVD

At present, the global market for precision medicine has exceeded 60 billion US dollars, of which the precision diagnosis field is about 10 billion US dollars. It is expected that by 2030, the relevant market scale is expected to exceed the trillion yuan mark, and precision medical care will provide a 100 billion blue ocean diagnostic market.

As of August 2017, a total of 17 in vitro diagnostic companies were listed in China. China's biochemical diagnostics field is basically mature. Because of its low technical barriers, most in vitro diagnostic companies can participate. About two-thirds of the company has a number of products in the field. At present, most companies are also cultivating different subdivisions in molecular diagnostics, such as tumor molecular diagnosis and nucleic acid molecular diagnosis.

Under the trend of “combination of diagnosis and treatment”, the continuous updating of drugs and treatments has promoted the development of the in vitro diagnostic market. For example, in May 2017, Merck's PD-1 inhibitor Keytruda was approved by the FDA for MSI-H/dMMR positive treatment, the first new drug approved in human anti-cancer history that can treat almost all tumors!

Prior to this, cancer treatment was based on the origin of cancer in the body, for example, for lung cancer and stomach cancer. The treatment of the PD-1 inhibitor Keytruda is based on the fact that any cancer, as long as it is MSI-H/dMMR positive, can be used.

In 2017, the FDA approved several genetic testing technologies for clinical use, paving the way for the development of precision medicine and in vitro diagnostics.

In May, "Natural Medicine" magazine published the world's first sequencing of advanced cancer in 10,000 people. This is a big data tumor genetic variation project based on second-generation sequencing technology, which will help open a new model of cancer diagnosis and treatment.

In June, the FDA approved Thermo Fisher's first NGS-based assay for NGS companion diagnostics for a variety of new non-small cell tumors, allowing doctors to find matching treatments for patients in a matter of days.

In December, the FDA approved the launch of Foundation Medicine's in vitro diagnostic test FoundationOne CDx, a milestone in genetic testing and in vitro diagnostics, and clarified the FDA's determination to advance the market for genetic testing.

The breakthrough of treatment means is gradually realizing the concept of precise medical treatment of "same disease and different treatment, different diseases and the same treatment", and the "early diagnosis" era of cancer is also slowly coming. As we all know, the market for early diagnosis of cancer is very large, and the cure rate of early cancer is very high. It is urgent to improve the early diagnosis and treatment of the tumor ecological chain.

The development of IVD industry is inseparable from the advancement of popular technology

In the field of genetic testing, the most fiery of course includes gene sequencing and liquid biopsy diagnostic techniques.

Gene Sequencing

Gene sequencing is a hotspot in the field of molecular diagnostics for nearly 5 years, and it is also the fastest growing sub-sector in the field of molecular diagnostics. Gene sequencing enables the analysis of gene sequences to predict the likelihood of multiple diseases.

Gene sequencing technology can lock down individual disease genes, prevent and treat them in advance, and combine big data to lock in more disease characteristics. In recent years, the cost of molecular diagnostics (especially NGS) has been greatly reduced, meaning that more patients will be exposed to molecular diagnostics.

At present, the clinical application of genetic testing is very extensive, including reproductive health, tumor prevention and control, pathogen analysis, transplantation matching, complex diseases, etc. Among them, non-invasive prenatal detection of NIPT is currently the most mature genetic testing technology.

Many companies in the genetic industry are involved in the clinical application development of gene sequencing. Foreign representative companies include Illumina, Thermo Fisher, Roche, etc. Domestic enterprises use Huada Gene, Boao Bio, and Golden Field Test. In 2015, the global gene sequencing market was 5.9 billion US dollars, and it is expected to reach 13.8 billion US dollars by 2020, with a compound annual growth rate of 18.7%. It is expected that the 2018 disease early screening + precision medical company accompanying treatment will become the dominant.

Liquid biopsy

Liquid biopsy is the most exciting breakthrough in the field of cancer diagnosis. Because of the need for tissue puncture, non-invasive specimens such as blood or urine are used to diagnose and evaluate disease using techniques such as high-throughput sequencing. Compared with traditional tissue biopsy, liquid biopsy has the advantages of small side effects, simple operation, and repeated sampling.

In addition, the medical cost of liquid biopsy is relatively low. At present, the main test substances for liquid biopsy include CTCs, ctDNA, and exosomes. In addition, new studies have found that blood components such as platelets can also be used for detection. Clinically, it is mainly used for cancer screening, concomitant diagnosis, postoperative examination, and non-invasive screening.

The field of liquid biopsy has gathered a lot of "unicorn" company inputs, such as Grail, Idea Di, Aide Bio, Berry and Kang, WuXi PharmaTech and so on. In January 2018, Aide Bio, a representative of China's liquid biopsy field, announced that its gene detection kit Super-ARMS® EGFR has become the first ctDNA detection kit approved by the accompanying diagnostic reagent standard in China. The EGFR gene mutation status of cell lung cancer to screen patients for EGFR-targeted drugs.

According to Kalorama Information, the global liquid biopsy market in 2016 was 394 million US dollars. The market size is expected to be 1.398 billion US dollars in 2021, with a compound annual growth rate of 28.8%.

Because liquid biopsy has the advantages of clinical diagnosis and drug monitoring, precision treatment will strongly promote the application of liquid biopsy. At the same time, as the cost of genetic testing decreases, the diagnostic cost of liquid biopsy will also decrease.

Although there are still questions about the accuracy of liquid biopsy results, there is still a long way to go for truly extensive clinical applications, technological breakthroughs and standard specifications, but liquid biopsy will undoubtedly bring new benefits to cancer patients and researchers. hope.

Source: Health

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