Release date: 2016-09-08
Cheng Shiming, deputy director of the Center for Tuberculosis Control of China CDC, revealed during the investigation in Guangzhou recently that according to the upcoming “13th Five-Year Plan†for tuberculosis prevention and control, by 2020, 100% of municipal-level designated medical institutions need to have drug susceptibility Test, strain identification and molecular biology diagnostic capabilities, 80% of the central and central, 70% of the western counties need to have the ability to conduct molecular biology testing.
Analysts believe that at present, more than 3,000 county-level medical institutions in China have almost no molecular biology testing capability for tuberculosis, which is a rare opportunity for enterprises engaged in new diagnostic technologies for tuberculosis. A rough estimate, according to the current market price of molecular diagnostic instruments of 150,000 yuan / Taiwan, and the average annual capacity of 1000 reagents per instrument, the market capacity will reach 600 million yuan a year, and the reagents are sold in the vaccine. It will continue to grow before widespread adoption.
New technologies such as molecular diagnostics will be promoted
"Before 2020, there will be no new tuberculosis vaccines to be marketed. Accelerating the new diagnostic technology for tuberculosis is the focus of tuberculosis prevention. At the same time, new diagnostic tools will gradually be included in the scope of primary health insurance, and will accelerate the supply of new diagnostic reagents." Shi Ming pointed out.
Tuberculosis prevention and control has always been a difficult problem in the medical field. One of the main reasons is the lack of accurate and effective pathogen laboratory diagnostic methods. The commonly used detection method in China is the sputum smear method, which has a detection capacity of only 15%, which is easy to cause the patient to miss the test; and the detection period of the sputum culture method as the diagnostic diagnosis standard is up to a month, which may delay the optimal treatment period of the patient.
To this end, the State has made efforts to promote the research and development and industrialization of new diagnostic technologies for tuberculosis in the "12th Five-Year" Science and Technology Major Special Project - Infectious Disease Prevention and Control, and strive to control the scope of disease and disease from the source and significantly reduce the burden of treatment. Among them, the constant temperature PCR amplification technology represented by Dio Bio is an important focus in practice. The constant temperature PCR amplification technology has the characteristics of high efficiency, low cost, simple equipment and convenient operation. It is especially suitable for rapid screening of comprehensive medical institutions and the promotion and use of county-level grassroots disease control units.
Segment companies are getting attention
As the lead unit of the national “Twelfth Five-Year Plan†infectious disease project, Diao Bio has independently developed the first domestically-recognized CFDA-certified Mycobacterium tuberculosis thermostat fluorescence detection system DeFast.TB. A nucleic acid detection solution for Mycobacterium tuberculosis complex consisting of proprietary instruments and supporting reagents.
In 2015, the National Health and Welfare Commission's Disease Bureau recommended the new diagnostic technology for tuberculosis in the country. It is recommended that the constant temperature amplification method be promoted and used in disease control systems and major hospitals at or above the county level. In addition, the company is in the CFDA registration of the tuberculosis infection immunodiagnostic product SPOTest, clinical trials and international similar products have a year-on-year competition.
It is worth noting that the company's pioneering international leading tuberculosis diagnostic products have also entered clinical validation, and it is expected to solve the world problem of bacteriological TB diagnosis. In the next step, Diao Bio will play the role of two major research and development platforms, including molecular and immunological research, longitudinally deepen the diagnosis and vaccine research and development of tuberculosis, and develop other major infectious disease detection technologies in a horizontal direction, striving to become the leader of IVD diagnosis industry for infectious diseases.
It is reported that the company's M. tuberculosis thermostat fluorescence detection system DeFast.TB has signed a total of 28 terminal customers. Among them, there are 10 provincial and municipal specialized hospitals, 4 provincial-level disease control, and more than 600 instruments have entered the province's 2016 CDC centralized procurement plan. The company has started the A round of financing plan, and it is estimated that the sales in 2016 will reach 40 million yuan, and the net profit will be 10 million yuan.
Source: China Securities Journal · China Securities Network
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