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Molecular diagnostics industry: "2 X" market pattern is now "embryonic"

Molecular diagnostics industry: "2 X" market pattern is now "embryonic"

In vitro diagnostics (IVD = In Vitro Diagnosis) refers to products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) outside the human body to determine disease or body function. In vitro diagnosis is called "doctor's eyes". Diagnosis includes detection, analysis, judgment and other links, and detection is the first link. In vitro diagnosis is divided into four categories according to test methods, biochemical diagnosis, immune diagnosis, molecular diagnosis and bedside detection (POCT).

14

2016

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06

It is said to be the smallest PCR detector in the world.

It is said to be the smallest PCR detector in the world.

Whether it is medical diagnosis or environmental testing, people need small and portable testing equipment. Therefore, the compact PCR detector came into being. Recently, the Canadian Spartan Bioscience company launched a claimed to be the world's smallest molecular diagnostic equipment.

14

2016

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06

Seven major violations of in vitro diagnostic reagents (IVD)

Seven major violations of in vitro diagnostic reagents (IVD)

In vitro diagnostic reagent (IVD) involves the whole process of diagnosis and treatment of diseases such as diagnosis, treatment plan selection, curative effect evaluation, etc. The demand is large, which is related to the vital interests of the people. The State Administration has successively issued the notice on printing and distributing the work plan for sampling and testing of in vitro diagnostic reagents, the notice on printing and distributing the work plan for risk investigation of in vitro diagnostic reagents, the notice on printing and distributing the work plan for special rectification of in vitro diagnostic reagents, and the notice of the general office of the State Administration on printing and distributing the work plan for quality evaluation and comprehensive management of in vitro diagnostic reagents.

07

2016

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06

IVD technology innovation favored by capital

IVD technology innovation favored by capital

Recently, CFDA released the 2015 annual medical device registration report. According to the report, 7530 medical device registrations were approved in 2015, of which 2707 were in vitro diagnostic reagents, accounting for 35.9. From the first and continuation of the registration data, in vitro diagnostic reagents in the corresponding registration of the product ratio occupies a clear advantage.

07

2016

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06

In vitro diagnostic industry rapid development independent laboratory market space is large

In vitro diagnostic industry rapid development independent laboratory market space is large

Recently, the medical information network released data show that in 2015 China's in vitro diagnostic (IVD) market size of about 36.3 billion yuan, the industry growth rate of 30%. The industry as a whole presents the characteristics of frequent technological innovation, variety diversification and high quality requirements. In vitro diagnosis involves biochemical diagnosis and molecular diagnosis of laboratory medicine. Compared with the overall growth rate of the pharmaceutical industry into a single-digit development status quo, in vitro diagnostics still enjoy a high-speed growth trend of 20% to 30%, the high business climate is expected to continue.

26

2016

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05

"Small and beautiful" IVD or sudden rise

"Small and beautiful" IVD or sudden rise

The rising IVD (in vitro diagnostics) industry in China should be given enough attention as a new industry.

15

2015

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12

China's version of the precision medical plan will be launched

China's version of the precision medical plan will be launched

The National Health and Family Planning Commission reported on November 30 that my country is currently formulating a "precision medical" strategic plan, which may be included in the "13th Five-Year" major science and technology projects.

03

2015

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12

How much do you know about the business requirements of in vitro diagnostic reagents?

How much do you know about the business requirements of in vitro diagnostic reagents?

In vitro diagnostic reagent management is divided into medical device management and drug management. Here we mainly explain the in vitro diagnostic reagents for the management of medical devices: including reagents, kits, calibrators, quality controls and other products that can be used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. It can be used alone or in combination with an instrument, appliance, device or system. In vitro diagnostic reagents for drug administration are those used for blood source screening and labeled with radionuclides.

03

2015

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12

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