Clinical Validation And Cost Advantages Of Domestic Kit For "Epidemic Prevention"

The epidemic of new crown pneumonia is spreading all over the world, and many countries and regions are facing the pressure of detection. Domestic manufacturers of kits have also helped the kits "go to sea" by donating money or selling sea routes.

"With the development of overseas epidemic situation, there may be a shortage of test reagents. Chinese kits can be used as supplements. In the past, home-made in vitro diagnostics accounted for only a small share of the global market, and nearly half of the market was occupied by four in vitro diagnostic tycoons SIEMENS, Abbott, Roche Diagnostics and Denmark. A sales manager from a domestic reagent box manufacturer told the twenty-first Century business reporter.

Since the outbreak of the new crown pneumonia, two new crown virus detection kits have been developed by domestic biological companies. One is a new coronavirus nucleic acid reagents, one is a new coronavirus immunoassay reagent, which can be assigned to molecular diagnosis and immunodiagnosis in the IVD (In Vitro Diagnosis) market. Most of the kits currently approved by the State Administration for drug administration are nucleic acid detection kits, and nucleic acid detection is still the "gold standard" for the diagnosis of new crown pneumonia. Exporting to the global market, domestic kit still has the advantages of first clinical and cost.

In February 24th, Chengdu Boao Jingxin Biotechnology Co., Ltd. produced respiratory virus nucleic acid detection kits in the reagents workshop. Xinhua News Agency

Cross the threshold of market access

The first step is to break through the overseas market access. How to enter various countries' channels has become a major problem at present.

At the beginning of March, four enterprises of Zhijiang biology, Huada gene, Da'an gene and Cape biology announced one after another that the new crown kit produced by themselves was approved by the European Union CE and had the access conditions of the EU market.

In addition, the Chinese new gene announced its new crown nucleic acid detection kit in March 2nd, which has obtained the free sales certificate of the in vitro diagnostic medical device of the European Union (English full name "Free Sales"). Certificate, "FSC", in addition to sales in the European Economic Area (EEA), the product can also be sold outside the European Economic Area (EEA) without the signing of mutual recognition agreement (MRA) and recognition of CE logo. At present, some manufacturers who have passed the fast examination and approval in China are applying for EU CE certification.

The head of an overseas container business in Southern China told the twenty-first Century business news reporter that at present, Japan and Korea have strict control over the import of the kit, and the kit must be registered locally before it can be imported. In addition, during the epidemic period, domestic kits are strategic materials, and the relevant departments have stricter control over the approved kits in China. Therefore, at present, the number of kits exported to Japan and Korea is not large. They have received hundreds of thousands of overseas lists, but because of insufficient supply, only about twenty thousand kits have been produced.

Another sales manager who conducted in vitro tests told the twenty-first Century business reporter that the current domestic nucleic acid detection kit is relatively productive. The company has exported more kits to some countries with heavy epidemics, and has exclusive agents in Iran and Thailand, but most of the overseas markets have not yet been sold.

In vitro detection of market spring

At present, there are more than 1200 molecular diagnostics related enterprises in China. Most of them are concentrated in economically developed areas, forming industrial agglomeration areas represented by Shanghai, Guangdong, Sichuan, Zhejiang, Shandong, Beijing, Tianjin, Hebei, Hubei and Jiangsu.

The epidemic is expected to have an impact on the development of molecular diagnostic industry in China. "After this outbreak, many enterprises will pay more attention to the field of molecular diagnostics, and take relevant products in this field as an important business development route," said Zhu Yaoyi, director of the China Medical Device Industry Association external diagnostic branch.

In recent years, with the increase of policy support, the research and development of detection reagents in China has developed rapidly. The molecular diagnostic kit has basically been made domestically. The domestic molecular diagnostic instruments occupy a certain share of the market in the intermediate end instruments (such as nucleic acid extractor, PCR diffuser, nucleic acid molecular hybridization instrument) which are relatively easy to break through, and the gene sequencer is also available. Accelerate the realization of localization. This is also the main reason for the rapid response of the molecular detection industry after the outbreak of the new crown pneumonia outbreak.

Taking Hua Daji as an example, it is currently working with the Brunei Ministry of health, the Ministry of public health of Thailand, the Nigeria National Medical Research Center (NIMR), the National Health Laboratory of South Africa, the National Institute of infectious diseases (NICD), the Hongkong and Taiwan regions of China, to cooperate in the supply of new coronavirus kits and other pathogen monitoring. The technology company Curetis Group, based on Ares Genetics in Austria, introduced the PCR and gene detection kit developed by Huada group to new European coronavirus for laboratories in Europe.

However, the in vitro diagnostic reagents industry started relatively late in China, and is still lagging behind in Europe and America. Biochemical materials such as diagnostic enzymes, primers, invertase, probes and other biological products upstream of the molecular diagnosis industry chain, high purity sodium chloride, glutamic acid and other fine chemicals and extraction media materials are still mainly monopolized by foreign giants such as Roche, Meridian life science, Solulink, Surmodics and so on. Only a few manufacturers in China produce individual products, and the scale is small.

After the outbreak of the new crown pneumonia, some IVD tycoons, such as Roche, responded quickly, donated a full-automatic nucleic acid detection system, and announced the detection plan for the 2019 new coronavirus through the WHO official website.

But at present, the domestic kit still has its own unique advantages.

"If regular reagents are developed, the cost will be high, and the cycle will be longer, because clinical practice is needed. But this time the situation is urgent, many products are emergency examination and approval, first put in the clinical test results, so the cycle is shorter. Our current reagent export is clinically validated, so domestic manufacturing still has advantages. " An in vitro testing industry in Southern China said to reporters on twenty-first Century economic report.

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