FDA encourages the development of gene sequencing free of pre Market Review

Source: ihealth 2017-11-07 a drop of blood can check cancer, a saliva sample can find the risk of genetic disease, gene testing has become the latest health trend This kind of gene detection technology which is directly facing consumers (DTC) is constantly improving People can mail a small saliva sample, get the results directly from the website of the test provider, and know their risk of genetic disease Gene sequencing can also help us learn more about our health risks, change our lifestyles, and choose healthy food, drink and daily life As our interest in genetic risk information continues to grow, so do our business opportunities Gene sequencing companies are flocking around, saying it can help people understand the health risks of their genetic and other diseases Domestic gene sequencing companies have also exploded Among them, the leaders have been valued at billions and obtained multiple rounds of financing The latest company, anouta C round financing raised "nearly $105 million", Guotai Junan investment group and Ping An venture capital leading investment SBCVC and Saif China also participated in this round of financing But this kind of test is not only to assess personal health and provide a lot of risk information, but also to have risks - if it provides information that may be wrong or misleading For example, a person at risk of coronary heart disease was genetically tested and told there was no risk So, eat and drink a lot, and throw the preventive medicine into the dustbin, which may cause more damage How to effectively supervise this booming DTC gene detection? "(DTC genetic testing) presents a unique challenge to FDA regulation because these technologies are not very consistent with our traditional risk-based management approach." Scott Gottlieb, director of the U.S Food and drug administration, said in a statement "FDA is adjusting its regulatory framework to be more flexible and creative to meet the challenges of new technology platforms In terms of personal gene sequencing, FDA is trying to achieve a balance between providing consumers with an effective way to conduct these tests without sacrificing the quality of FDA regulation " He said In this regard, FDA is introducing innovative regulatory measures to encourage the development of gene sequencing, reduce the burden, and establish a risk-based, efficient, safety and effectiveness based path FDA has issued three new innovative measures for reference These specific measures are: 1 FDA pre cert The pre certification program focuses on digital medical products by evaluating digital health technology developers or software developers rather than specific products 2 Allow gene testing to be exempt from pre Market Review under specific conditions "If finalized, the providers of these genetic tests will only need a one-time review to ensure they meet FDA requirements, after which they will be able to enter the market, and there is no need for further review of the new genetic tests." Said Gottlieb, FDA director This is the latest regulatory innovation, more flexible FDA has also established independent special controls for gene testing by category order, which lists the requirements that these sequencing must ensure the accuracy, reliability and clinical relevance of the test, and describes the types of research and data needed to prove specific types of gene testing 3 A comprehensive policy framework will be issued soon, which will more clearly describe how to regulate the safety and effectiveness of cell-based regenerative medicine.