American actress Angelina Jolie can be said to be the "speaker" of genetic testing to prevent disease. She has been diagnosed with familial genetic defects and has a higher risk of breast and ovarian cancer, so she receives prophylactic bilateral breast and Ovariectomy. It is also her move that makes the public pay more attention to the role of genetic testing in preventing disease. In the country, you read Julie's news. If you want to test the high-risk tumor cancer susceptibility gene, you will find it difficult to find a reliable genetic testing channel as an ordinary person.

why? Because of the domestic genetic testing market, the average person has low awareness of genetic testing, and the companies in the industry are uneven. Some sales representatives even exaggerate the effects in order to obtain customers, deify the genetic testing, and most importantly, the average person In the hospitals that are trusted, in addition to the non-invasive genetic testing for pregnant women, other genetic testing products are difficult to figure out. Today we will talk about the fact that regular genetic testing products have to go through a few passes.

Why is the threshold for genetic testing used in hospitals so high?

First over the supervision

The medical institution can be said to be the largest customer of the genetic testing company for the clinical medical market. After all, the Chinese people believe that doctors recommend it. Once the medical institution market is opened, the 100 billion-level market will follow.

There have been two introductions in the genetic testing industry. There are two types of companies for genetic testing services in the middle and lower reaches. One is for scientific research and medical institutions, with Huada Gene, Berry and Kang, Dean Diagnostics, WuXi PharmaTech, Jin Large companies such as domain testing are representative, and one type is directly oriented to consumers, such as 360 genes, microgenes, and genes. There are also sales agency companies that have channel resources such as hospitals, medical institutions, and insurance companies.

For genetic testing products to be used in clinical medicine, the first thing to do is to supervise this. It requires the approval of the State Food and Drug Administration (CFDA), and the medical institutions that provide genetic testing and diagnosis need the approval of the National Health and Family Planning Commission. Currently, only the non-invasive prenatal genetic testing (NIPT) product has these two elements. Other products, such as cancer cancer, genetic disease genetic testing, etc., must enter the medical institution and apply to CFDA for registration and approval.

As a technology applied in the medical field, the regulatory authorities escort through supervision, strict supervision is understandable, but the longer approval and registration procedures also lengthen the time for technology to market.

Taking non-invasive prenatal genetic testing as an example, in September 2010, it officially entered the domestic clinical market. In February 2014, it was stopped by the national regulatory authorities. In July 2014, several large companies' products were successively approved by CFDA, 2014. At the end of the year, the National Health and Family Planning Commission designated 109 pilot medical institutions. This product was officially approved for supervision and was gradually accepted by the hospital. However, it only covers the top three hospitals in the first and second tier cities.

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