A few days ago, the Food and Drug Administration issued the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents (Revised Draft for Solicitation of Comments)" has entered the final stage. It is reported that the legislative basis is mainly to regulate the registration and filing of in vitro diagnostic reagents. It will apply to applications for registration of in vitro diagnostic reagents, filing of in vitro diagnostic reagents, and supervision and management activities in my country.
　　
It is observed that the application scenario of in vitro diagnosis in China is getting more and more attention with the development of the epidemic. On the industrial side, ecology has slowly moved from traditional hospital inspection departments to third-party diagnostic laboratories, physical examination centers and primary health care institutions. The layout of the in vitro diagnostic industry is becoming more and more broad.
　　
Among them, a large proportion is about biochemical diagnosis, which is an auxiliary means based on hospital examination. Doctors help patients to detect physical indicators by prescribing blood routine, urine routine, gastric function and other diagnoses. For distributors, this has been an important sales port for in vitro diagnostic reagents and related consumables.
　　
The biological diagnosis is currently the hottest and has been hailed as the next industry outlet by many industry experts. It mainly uses molecular biology technology to sequence the genetic structure of the patient's body, so as to judge the precursor and incidence of the disease in the patient's body.
　　
For the field of gene sequencing, how will it develop in the future, which branch will be more and more attention by people, in this regard, the industry's well-known R & D personnel Chen Weiming pointed out:
　　
After 2000, gene research and sequencing began to rise in China. At present, the cost advantage of gene sequencing is still relatively large, and it has gradually begun to replace traditional testing. Moreover, many platforms are also supported by rich data to obtain more samples, and the test results are more and more recognized by the industry.
　　
Data and bioanalysis have always been the two most important key elements provided by gene sequencing service providers. At present, this field is mainly used in medical and non-medical fields, and the scene will be different.
　　
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High-end department is still a replacement problem
　　
"At present, the earliest and most mature application is still in the field of scientific research, which is mainly oriented to the cooperation between universities and enterprises, and is basically in the field with the most research and development achievements," Chen Weiming pointed out.
　　
Clinically, it is more used in some maternal and child health hospitals: it is used for infant testing, maternal testing, etc. This part has a relatively wide range. Many companies believe that the commercial potential is huge and the market has the highest breadth.
　　
Another level is mainly for some medical beauty testing, sports fitness testing, skin testing, nutrition testing, elderly care and prevention. Meanwhile, cancer screening remains one of the hottest. In terms of market capacity, the global gene sequencing market has reached more than $10 billion in 2018 and is expected to grow to about $25 billion after 2020.
　　
Chen Weiming pointed out in particular that chemiluminescence is gradually becoming the mainstream immunodiagnostic method in China.
　　
In immunodiagnosis, the localization of low-end equipment and reagents is relatively high. In this field, foreign brand invasion is relatively small, but the most high-end is still monopolized. This has also become the key to China's domestic concentration in the future.
　　
Different chemiluminescence diagnosis has different principles, mainly divided into chemiluminescence, direct chemiluminescence and enzymatic chemiluminescence.
　　
Chen Weiming pointed out that the higher sensitivity is enzymatic chemiluminescence. At present, China's Mindray, Antu Biology, Mike, etc. have related industrial layouts, and the highest chemiluminescence is electrochemical luminescence. This is mainly the use of motor light-emitting light, with a long time, high intensity and controllable characteristics, and can be reused, environmental protection is also better.
　　
But this part is mainly monopolized by some foreign enterprises, and at the technical level, the weaker the ability of domestic enterprises.
　　
It is understood that the application of electrochemical luminescence is the most broad, currently in the field of diabetes, allergic reactions and anemia, bone markers and so on have a very strong application. Especially in the emergency department, it can be used to detect the condition of vital organs such as high blood pressure, lungs and heart.
　　
At present, the risk of the emerging industry of in vitro diagnosis is still relatively large, for example, the homogenization service in the field of gene sequencing is relatively serious, many suppliers are joining, and the industry competition and price are still relatively large impact.
　　
In terms of cost control, there will also be some companies that arbitrarily reduce prices in order to win more markets, and there are also regional monopolies in sales. At the same time, the technology of updating iterations continues to accelerate. If companies cannot adapt to relevant technology changes as soon as possible, There will be very big risks.
　　
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