The Risk Management Of Early Cancer Detection Project Based On NGS Gene Panel Method

With the emergence of the second Generation of high-throughput sequencing technologies,genomics researches show a tendency of explosion.This service based on the Genetic testing of high-throughput sequencing technology quickly enter into our lives,and greatly improved our lives,we call that is "precision medical treatment".Precision medical starts from all aspects are affects our lives.The early cancer screening circulating tumor DNA is one of the new projects.They have clinical drug screening,early intervention and evaluation after the meaning.Early cancer screening is based on circulating tumor DNA detection that can be detected in cancer at early stages of trace amounts of highly sensitive detection technology.It is followed with the golden rule of medical system in cancer treatment "early detection,early treatment".This technology is able to trace free circulation of free extraction and detection,cancer genome in early stage of cancer is to identify in the early intervention of medical intervention,thereby this technology can help to reduce the damage to the patient,provide accurate guidelines,and monitoring of cancer recurrence after treatment.Therefore,how to effectively and accurately apply this technique,improve the detection precision,the accurate of cancer diagnosis,effective of drugs cured that is the key factor.This thesis will pay more attention in the whole precision medical industry.This thesis reviews the research on the direction of precision medical and conventional medical risk management.We expounds the methods and ideas of routine detection and medical treatment risk management.In this thesis,through questionnaire based on the Gene and the process methods.A Panel of high-throughput sequencing a variety of early cancer screening can lead to the risk of a number of factors:the specimen risk,equipment risk,reagent consumables risk,quality risk,documents and records risk,technology risk and other risks,etc.At the same time,according to all the research about medical treatment and medical detection after the comprehensive analysis of literature.The failure mode and effects analysis(FMEA)is a useful model that can measure the study of project risk.In this thesis,in combination with the results of the analysis of questionnaire survey and sorted out according to the fishbone diagram,it is concluded that the close influence Gene based on ctDNA Panel high-throughput sequencing cancer early screening of the key factors mainly are:technical risk,reagent quality risk,transport risk,operation risk,equipment risk.That is to say in the industry:person,machine,material,law and ring.And the details of each factor for effective separation,on the basis of the vector and each link of the direct relation in the core of key risk factors and combining the domestic and foreign research present situation and industry actual implementation method to determine the effects of five types of risk factors and project and failure(FMEA)method for further analysis and put forward the assumption,in this paper,the research model is established.Based on the improvement and evaluation of risk factors,the effective risk management scheme is obtained.